Fashion And Beauty

Women with early-stage breast cancer who have undergone breast augmentation may be treated successfully with a partial-breast radiation treatment called brachytherapy, according to a study presented today at the annual meeting of the Radiological Society of North America (RSNA). Patients treated with brachytherapy have better cosmetic outcomes and avoid the risk of the implant hardening, compared to patients who undergo whole-breast radiation therapy.

“We are seeing an increasing number of breast cancer patients with augmentation,” said Robert R. Kuske Jr., M.D., clinical professor at the University of Arizona Health Sciences Center and radiation oncologist at Arizona Oncology Services in Scottsdale, Ariz. “By nature, these women are concerned about their appearance and we need to have options for them.”

According to the American Society of Plastic Surgeons, breast augmentation is the most popular cosmetic surgery in the U.S. with 347,500 procedures performed in 2007. This represents an increase of 64 percent since 2000.

Approximately one in eight women who undergo breast augmentation will develop breast cancer at some point in their lives.

The most common breast cancer treatment for patients with breast implants is skin-sparing mastectomy and implant exchange. Whole-breast radiation therapy after lumpectomy is an option, but carries a substantial risk during the healing process of scar tissue wrapping around the implant, causing it to become rock-hard and extremely painful. This condition, known as capsular contracture, also distorts the appearance of the breast.

Dr. Kuske set out to determine if partial-breast radiation with brachytherapy might offer a better outcome for women with implants wishing to avoid mastectomy.

Breast brachytherapy is a radiation treatment that can be given in higher doses to a small, targeted area of the breast after lumpectomy. Radioactive “seeds” are guided into place through small plastic tubes, or catheters, with the aid of imaging and a computer. The seeds emit high doses of radiation in short bursts.

Scar tissue is minimal, the implant remains unaffected and treatment time is shortened from 6 1/2 weeks with whole-breast radiation therapy to five days with brachytherapy.

For the study, 65 women who were diagnosed with small, early stage malignant tumors were treated with brachytherapy after a lumpectomy. The women received two doses per day, separated by six hours, over a five-day period. Follow-up was six months to five years. None of the patients experienced tumor recurrence during the follow-up period. Cosmetic outcome was determined to be good to excellent in 100 percent of patients with 95 percent judged excellent. Implant hardening was not observed in any of the patients.

“Compared to traditional treatments, brachytherapy offers an excellent alternative for these women,” Dr. Kuske said. “It offers very high rates of tumor control with fewer side effects and is easier on their lifestyle.”

Notes:

Disclosure: Dr. Kuske is a consultant for Nucletron and for Cianna Medical.

Copies of RSNA 2008 news releases and electronic images will be available online at http://www.RSNA.org/press08 beginning Monday, Dec. 1.

RSNA is an association of more than 42,000 radiologists, radiation oncologists, medical physicists and related scientists committed to excellence in patient care through education and research. The Society is based in Oak Brook, Ill. (http://www.RSNA.org)

For patient-friendly information on brachytherapy, visit http://www.RadiologyInfo.org

Bargains on consumer goods and services may be designed to encourage spending in tough economic times, however when related to cosmetic injections like Restylane, Juvederm or Botox, the multi-specialty Physicians Coalition for Injectable Safety warns that discounts raise a red flag. “Bargain prices, deep discounts or purported sales on cosmetic injections are warning signs of potential counterfeit or illegally imported cosmetic injectables, or an injector who is inexperienced or does not specialize in the procedure,” cautions facial plastic surgeon and Coalition spokesperson Mary Lynn Moran, MD of Woodside, CA. “Consumers must adopt a buyer-beware approach to offers that seem too good to be true.”

Unlike common over-the-counter and prescription medications, cosmetic injectables do not have lower-priced generic alternatives. “FDA approved, branded cosmetic drugs or devices are sold to all physicians at defined prices,” said Coalition leader, plastic surgeon Renato Saltz, MD of Salt Lake City, UT. “There are generic lower, priced brands, no sales for physicians who stock up on injectables and no bona-fide sources who sell genuine product at lower than market prices, and therefore there are no deep discounts physicians can pass along to consumers.” Some injectable brands do, however, offer post-treatment rebates directly to the consumer. The Coalition warns consumers that deep discounts or savings can potentially risk:

- Counterfeit or illegally imported substances, resulting in potential health risk, injury or serious complications
- Illegally compounded and unbranded substances, resulting in potential health risk or injury, and unpredictable outcomes
- Diluted or improperly administered substance, potentially resulting in little or no outcome, a poor outcome, or a short duration for results obtained
- Bait and switch, or pressure to elect additional or unnecessary procedures
- Unqualified providers, lowering prices to create demand, and potentially risking poor or undesirable outcomes

Consumers can find average U.S. costs for cosmetic injections listed by U.S. FDA approved brand at http://www.injectablesafety.org/html/ataglance.php.

The Coalition, charged with educating consumers on safe choices in cosmetic injections and eradicating the use of counterfeit and illegally imported cosmetic injectables suggests all consumers follow very cautious steps for both safe, and positive outcomes:

- Doctor: Ask specifically about your doctor or injectors qualifications. Choose a doctor who specializes in treating all cosmetic concerns of the face, such as a board certified plastic surgeon, facial plastic surgeon, oculoplastic surgeon or dermatology and who examines you, prescribes and performs cosmetic injections in a licensed and properly equipped medical facility. Establish a positive and on-going relationship with your doctor and follow-up as directed. A nurse or physician’s assistant may perform your injection if you elect, but a licensed physician must prescribe the treatment.

- Brand: Ask specifically the brand name of the injectable recommended for you, the approval status of regulatory agencies in the country where you will be treated (the U.S. FDA in the United States) and about any potential outcomes and the likelihood of adverse events. If your doctor does not offer, ask specifically to see the packaging and identifying marks that can verify authenticity, including the serial and lot number (which as a matter of proper procedure must be recorded in your medical chart). For reference, images of all U.S. FDA approved brand logos and packaging are available at. http://www.injectablesafety.org/html/ataglance.php.

- Safety: If you suspect your injector is not properly trained, is not following proper procedure or is injecting you with a non-branded, non-approved or unsafe substance, do not accept treatment. Follow-up by anonymously reporting suspected illegal activity to your local FDA field office that can be found at http://www.fda.gov/consumer/updates/oci072307.html.

To learn more about the benefits of cosmetic injections, the uses for approved cosmetic injectables, to plan for your treatment, see video of live, appropriately administered injectables and more visit http://www.injectablesafety.org and http://www.realself.com/injectable-safety-campaign.

The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, the American Society of Ophthalmic Plastic and Reconstructive Surgery, the International Society for Aesthetic Plastic Surgery and the Canadian Society for Aesthetic Plastic Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product.

Physicians Coalition for Injectable Safety

Join a 70-minute demonstration on the evaluation and cosmetic treatment of the face. The session will be hosted by dermatologists Susan H. Weinkle, MD, FAAD, Ashish C. Bhatia, MD, FAAD, and Wm. Philip Werschler, MD, FAAD, FAACS, who are experts in the field of facial rejuvenation.

The program provides hands-on demonstration of non-surgical techniques for facial rejuvenation using the latest advances in facial-shaping agents, and emphasizing the use of combination injectable products. Videotaped sessions will illustrate methods for facial assessment, describe how facial anatomy changes with aging, and provide insight on selecting the best agents and techniques for specific patient issues.

Drs. Weinkle, Bhatia, and Werschler share their clinical expertise in combining injectable facial products to obtain optimal results. Using patients of various ages, they demonstrate optimal techniques for the injection of facial-shaping agents, including calcium hydroxylapatite (Radiesse(R)), collagen (Evolence(R), CosmoDerm(R)), hyaluronic acid (Juvederm(TM) Ultra, Restylane(R), Perlane(R)), and poly-L-lactic acid (Sculptra(TM)).

Ashish C. Bhatia, MD, FAAD is Assistant Professor of Clinical Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. An accomplished dermatologist, Dr. Bhatia has extensive experience in dermatology, dermatologic surgery, and cosmetic surgery. His expertise includes face and body aesthetic surgery, skin cancer therapy, Mohs Micrographic Surgery, laser surgery, and skin resurfacing procedures, as well as the treatment of common and rare skin conditions.

Susan H. Weinkle, MD, FAAD is board certified in dermatology, a Fellow of the American College of Mohs Micrographic Surgery and Cutaneous Oncology, and a Diplomate of the American Board of Dermatology. Dr. Weinkle has been in solo practice since 1984, specializing in Mohs Micrographic Surgery and cosmetic dermatology. She has held academic appointments at Stanford University Hospital, the University of California Irvine Medical Center, and most recently, at the University of South Florida.

Wm. Philip Werschler, MD, FAAD, FAACS, Assistant Clinical Professor, University of Washington School of Medicine, Seattle, Washington, is a past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery (ASCDAS), a Fellow of the American Academy of Dermatology (AAD), and a fellow of the American Academy of Cosmetic Surgery (AACS). Dr. Werschler has been an active leader his entire professional career in the development of selected cosmetic techniques and procedures for the concept of Non-Surgical Total Facial Rejuvenation (NSTFR), as a foundation for minimally invasive cosmetic renewal.

This CME online activity is jointly sponsored by Postgraduate Institute for Medicine and BioCentric, Inc. and is supported by an educational grant from Dermik Aesthetics and sanofi aventis.

Learn more about the latest in cosmetic treatment and view a preview for this program by visiting: OR-Live.com

A 70-minute demonstration on the evaluation and cosmetic treatment of the face.

OR-Live, Inc.

From frizzy perms to over-bleached waves, “bad hair days” could soon become a less frequent occurrence. Chemists report the first detailed microscopic analysis of what happens to individual hair fibers when they interact with each other, an advance in knowledge key to the development of improved shampoos, conditioners, and other products for repairing damaged hair, the researchers say. They presented the study at the American Chemical Society’s 236th National Meeting.

Embracing that adage, “Personal care begins with hair,” consumers now spend almost $60 billion annually on hair care products, one of the personal care industry’s largest market segments. Despite the increasing availability of new hair care products within the past century, many products are inadequate for tackling today’s rigorous hair treatments, the researchers say.

“Given all the new hair treatments out there, there’s a growing need to make hair feel more natural, especially for women,” says study co-author Eva Max, a doctoral student in chemistry at the University of Bayreuth in Germany. She notes, however, that researchers still are scrambling to put hair care on a firm scientific basis. The research involves “haptics,” the science of touch - how the subjective perception of touch connects to objective surface properties of hair and other materials

“For the first time, we present an experimental setup that allows measuring the subtle forces, both physical and chemical, that arise when single hairs slide past each other or are pressed against each other,” Max says. “The findings will help provide clearer strategies for optimizing hair care products.”

Max points out that conventional methods for testing the effectiveness of hair care products involve measuring the forces required to comb hair under standardized laboratory conditions. Test volunteers are also asked to assess hair feel, but this approach is largely subjective. A more scientific way to study hair conditioning is needed, the researchers say.

In the new study, the researchers invented a unique technology for analyzing hair that involves mounting individual hair fibers on a cantilever tip of an atomic force microscope and measuring their interactions as they touch each other. “The system will allow scientists to explore how different hair care products affect hair-to-hair interactions so that these products can be optimized in a more systematic fashion,” Max says.

The researchers used this new technique to analyze hair samples collected from volunteers. The samples, which were previously bleached, ranged from light blond to dark blonde in color.

The researchers found that hair feels rough and difficult to comb for two main reasons. On the one hand, mechanical damage to a hair’s surface, or cuticle, creates scaly projections that jut out at perpendicular angles to other hair fibers. When hair fibers slide past each other, these scales create more friction than smooth hairs, causing a rough feel and making hair more difficult to comb. To soften hair, conditioners must contain active agents to smooth-out these scales so that they produce less friction, the researchers say.

On the other hand, chemical changes occur when hair fibers interact. Negative charges build up on the surface of hair that causes repulsion between single hairs. This repulsion causes friction and makes hair rough and difficult to comb. To solve the problem, positively-charged polymers that neutralize the negatively charged surfaces are included in conditioner formula to provide a silky feel to hair.

But finding the right formula for repairing damaged hair is no easy task, notes Claudia Wood, Ph.D., a senior scientist at BASF in Bayreuth, Germany. In addition to hair interactions, many other external factors, such as humidity, water content of hair, and hair stickiness, all affect hair quality, Wood says.

The key to repairing these processes is to find the right ratio of beneficial components in a conditioner or shampoo that optimize hair feel, Max and colleagues say. This new method will allow developers of hair care products to achieve this goal more easily, giving consumers a more reliable product, the researchers say. Their study was funded by BASF Care Chemicals Division.
Charmayne Marsh
Michael Bernstein
American Chemical Society

Acne just seems to never go away for many adolescents. A new study published in the August issue of Archives of Dermatology reports results of a teen survey and finds that teens would pay about $275 to have never had acne. Researchers also found that adolescents said that they would be willing to pay more be free of acne than to have half of their acne cleared or to have clear skin with acne scars.

More formally known as acne vulgaris, the skin disorder impacts almost all adolescents and is often a factor that leads to anxiety, depression, embarrassment and social dysfunction. Cynthia L. Chen, M.D. (University of California, San Francisco) and colleagues write that, “Reducing the psychosocial impact of acne is considered one of the guiding principles for its clinical management and it is important to measure and evaluate this impact.”

Results from this study come from an analysis of 266 teen volunteers with acne from four public high schools in San Francisco. Chen and colleagues administered written surveys to the students that asked them to answer hypothetical questions such as how much of their lifetime they would forgo or how much money they would pay:

• To have never had acne,
• To be 100-percent acne-free from then on,
• To have 100-percent acne clearance but with visible scarring, or
• To have 50-percent acne clearance.

The survey also included questions for parents regarding their acne history and severity. Since parents usually pay for children’s acne treatments, they were also asked about their willingness to pay.

With the teens’ responses to the time trade-off questions, the researchers calculated current acne state utility scores by dividing the participants’ reduced life expectancy in years without acne by his or her life expectancy in years with acne. The average utility score for a teen in his or her current acne state was 0.961. Scores improved to 0.978 for 100% clearance, 0.967 for 50% clearance, and 0.965 for 100% clearance but with scarring.

The median price that teens were willing to pay to have never had acne was $275. For 100% clearance of acne, they were willing to pay $100. The median price of 50% clearance would be $10, and of 100% clearance with scarring would be zero dollars. Parents had somewhat similar responses to the willingness-to-pay analysis, indicating a median of $250 for their child to never have had acne, $100 for 100%, $100 for 50%, and zero dollars for 100% clearance with scarring.

As expected, teens who believe their acne is more severe are willing to trade more time and money for acne clearance than those who rate their acne as less severe.

“Knowledge of these patient preferences may help dermatologists balance clinical trial results with patients’ expectations of therapy,” write the authors. “Randomized, blinded, placebo-controlled trials have shown that three to four months of conventional acne therapy, including topical benzoyl peroxide, topical retinoids and oral antibiotics, typically produces reductions in lesion counts in the 40 percent to 60 percent range.”

They add that, “It has also been suggested that the incidence of scarring from facial acne approaches 95 percent…Thus, adolescents’ marked preference for total clearance over partial (50 percent) clearance or clearance with scarring suggests that physicians must weigh high patient expectations against these clinical data regarding efficacy and risk of sequelae.”

In an accompanying editorial, written by Marta J. VanBeek, M.D., M.P.H. (University of Iowa Hospitals and Clinics), “Dermatologists are keenly aware of the ways skin diseases may have a substantial impact on a patient’s overall quality of life. However, in an environment in which health expenditures are allocated by non-physicians, it is critical to demonstrate the burden of skin disease relative to non-dermatologic disease to funding sources, government agencies and the lay public.”

“In terms of social value, preference-weighted questionnaires are instrumental in evaluating the extent to which increased health care expenditures lead to patient benefits because they incorporate a summary description of health status, social values and life expectancy,” concludes Dr. VanBeek. “Fundamentally, utilities measure true patient preferences, uninhibited by physician assumptions. Such measurement refocuses physicians on the primary goal of our profession: improving the care of our patients.”

A Community-Based Study of Acne-Related Health Preferences in Adolescents
Cynthia L. Chen, MD; Miriam Kuppermann, PhD, MPH; Aaron B. Caughey, MD, MPP, MPH; Lee T. Zane, MD, MAS
Archives of Dermatology (2008). 144[8]: pp. 988-994.
Click Here to View Abstract

With news that the Government will not deregulate Class 3B and 4 Lasers and Intense Pulse Light Sources (IPL) on 1 October 2008 as planned*, Jenny Driscoll, Health Campaigner, Which? says:

“We’re delighted the Government has listened to consumers and industry, deciding not to deregulate cosmetic laser treatments in October**. Thousands more people would have been needlessly harmed or scarred if the proposals had gone ahead***, and it is encouraging to see that the consultation process has been effective.

“Now the Government must take the time to have a serious, in-depth look at this rapidly expanding industry. Current and future regulations must not only be effective and robust, but policed efficiently in clinics across the country, making sure consumers are protected. Laser treatments should change lives for the better, not the worse.”

* Private and Voluntary Healthcare, Care Standards Act 2000, Regulations and National Minimum Standards, Consultation Document

** The Government published its consultation paper on Private and Voluntary Health Care: Care Standards Act 2000′ in March 2008 which included partial deregulation of lasers and intense pulsed light sources - Class 3B or Class 4 laser products and intense pulsed light (IPL).

***The Government stated that cosmetic laser deregulation could cost the NHS an extra £1.8 million a year as well as doubling the rate of ‘adverse incidents’ such as people getting burns. (Source: Department of Health (March 2008) Private and Voluntary Healthcare: Care Standards Act 2000, [Appendix A: Deregulation of lasers and lights - possible effect on number of adverse incidents]).

What Which? has done:

- In June 2008 Which? submitted a response to the deregulation proposals which stated that the Government was basing its decision to deregulate laser treatments on an ‘inadequate assessment’ on the effects of such a move on both consumers and the NHS.

- In July 2008, over thirty patient groups, medical bodies, cosmetic clinics and industry representatives joined forces with Which? to oppose Government plans to stop regulating cosmetic laser treatments from 1 October. The groups signed a joint letter to Health Minister Ben Bradshaw MP, calling on him to halt Government plans to remove non-surgical laser treatments, like hair removal and skin treatments, from current healthcare regulation. Which? said that the Government had underestimated the financial impact of such a change on the NHS, the cosmetic treatment industry and the number of people burned as a result.

WHICH

Company will launch SmoothShapes at “EADV Congress” in Paris beginning today
Elemé™ Medical Inc., a private venture-backed aesthetics company building a franchise in the body shaping market with an initial focus on treatment of cellulite, announced today that it has received CE Mark approval of its FDA-cleared SmoothShapes® System. The Company also announced that it is launching the SmoothShapes device internationally at the “17th Congress of the European Academy of Dermatology & Venereology”, Sept. 17-21, Paris. The product launch will include an Elemé Medical-sponsored symposium: “Impacting Cellulite: A Discussion with SmoothShapes® Experts.”

The SmoothShapes® System uses a proprietary technology called Photomology® that features a unique mechanism of action combining dynamic laser and light energy with mechanical massage and vacuum. This process affects the tissue responsible for the appearance of cellulite-enlarged fat cells and inflexible collagen. SmoothShapes stimulates restoration of healthy cell activity by focusing on both the physical manifestations of cellulite and its underlying causes. Treatments provide improved appearance of cellulite with longer-lasting results that patients can see and feel.

“Based on our technology’s robust scientific foundation, we expect considerable interest in SmoothShapes from dermatologists attending the EADV Congress,” said Nancy M. Briefs, President and CEO. “These clinicians will place high value on the fact that the regulatory-approved claims about SmoothShapes are based exclusively on results obtained in rigorous, independent and ongoing clinical studies of our System. Consequently, we anticipate that SmoothShapes will be able to quickly establish solid traction in European markets.”

The Elemé Medical-sponsored symposium, “Impacting Cellulite: A Discussion with SmoothShapes® Experts”, will include a panel of international dermatology experts: Christine Dierickx, M.D. (Boom, Belgium); Nathalie Fournier, M.D. (Clapiers, France); Serge Mordon, Ph.D. (Lille, France); Klaus Fritz, M.D. (Landau, Germany); and, Michail Pankratov, M.D., Ph.D. (Vice President, Regulatory & Clinical Affairs, Elemé Medical).

About EADV

The European Academy of Dermatology and Venereology (EADV) advances excellence in clinical care, research, education, and training in the fields of Dermatology and Venereology. Its mission is essentially realized through its Congresses and Symposia, the publication of its official scientific journal, The Journal of the European Academy of Dermatology and Venereology (JEADV), and provision of CME accreditation.

About Elemé Medical™

Elemé Medical Inc., headquartered in Merrimack, N.H., is dedicated to providing market-leading technology in all areas of body shaping. SmoothShapes® System with pioneering Photomology® technology is a medical device with FDA clearance and CE Mark approval to market. The Company’s name, when spoken phonetically, suggests “lasers, medicine and aesthetics.”

Elemé Medical™

The American Society of Plastic Surgical Nurses presented its Plastic Surgical Nurses (PSN) Editor’s Award to Marlene Rankin, a Rutgers College of Nursing faculty member, and her two co-authors, during its annual convention in Chicago Nov. 1.

Rankin, clinical associate professor at The College of Nursing at Rutgers, The State University of New Jersey, and her co-authors, Carrie Carretta, an advanced practice psychiatric nurse, and Anna Jarosysnski, a Rutgers College of Nursing senior, were honored for their article, “Nursing Care of Posttraumatic Stress Disorder after Anesthesia Awareness,” published in the January/March 2008 issue of PSN.

Rankin said the award was most gratifying because she has mentored Carretta, a Lincroft, N.J. resident, and Jarosysnski, a Bayonne, N.J. resident. “Watching their development and growth,” said Rankin, “is enriching and has fulfilled my life in many ways.”

Carretta earned her master’s degree in nursing at Rutgers Graduate School of Newark and her baccalaureate degree at Rutgers College of Nursing. Rankin has mentored Jarosysnski since she was a sophomore Honors Scholar in 2005.

“It is wonderful to be honored for research you are passionate about. Receiving this award positively reinforces my role in improving plastic surgical outcomes and clinical care,” said Rankin, a Princeton, N.J. resident, said.

From its headquarters in Newark, Rutgers College of Nursing offers a broad range of academic programs on all three Rutgers campuses. The college offers a master’s program with unique practitioner specialties, a Doctor of Nursing Practice (DNP) degree, and was the first to offer a Ph.D. nursing degree in New Jersey.

Miguel Tersy
Rutgers University

A new study of breast cancer radiation treatment performed at 21st Century Oncology has found that the SAVI™ applicator delivered excellent cosmetic results with minimal side effects, for women who had not qualified for breast conservation therapy using a previously available balloon device.

Reporting on 12 recent cases, the 21st Century Oncology study found no incidence of potential side effects such as seroma (fluid collection), pigmentation change, fibrosis (scar tissue) or infection. Indicating the precision of the SAVI applicator, the maximum skin dose of radiation for patients never exceeded the prescribed amount. In 92% of the cases, the cosmetic result was rated “excellent.”

The research team was led by Constantine Mantz, M.D. of 21st Century Oncology, one of the first medical organizations in the nation to offer this new and improved approach in breast brachytherapy, a radiation treatment that is delivered from inside the breast.

The study will be presented as a scientific poster at the annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), to be held Sept. 21-25 in Boston.

Breast conservation therapy includes lumpectomy - the surgical removal of the cancerous tissue within the breast plus a small margin of normal tissue immediately surrounding the tumor - followed by radiation. SAVI is a single-entry, multi-catheter device that allows the physician to customize the radiation dose depending on the patient’s anatomy and precise configuration of the surgical site.

“Our study demonstrated that SAVI provides a well-tolerated therapy for patients who otherwise would not be able to safely undergo treatment with the previously available balloon device,” said Dr. Mantz. “SAVI offers the physician multiple catheters for radioactive source loading and therefore total control over radiation dose distribution.”

Explaining the advantages for both physicians and patients, Dr. Mantz said, “I can lightly load catheters near the skin or lung to limit exposure of these sensitive structures. Also, I can heavily load catheters deep within breast tissue, to increase the radiation dose to places where the patient is at risk for harboring microscopic disease. We are very pleased with our clinical outcomes to date with SAVI.”

Prior to doing the study, Dr. Mantz and his research team believed that the multi-catheter applicator’s design might offer a preferable alternative for patients whose tumor cavities were too close to the skin for treatment with the previously available balloon method. Patients whose tumor cavities are within 7 millimeters of the chest wall or skin surface are often disqualified for treatment with the balloon device because of a potentially severe lung or skin reaction to the radiation.

This study tested the hypothesis by using the SAVI device to treat 12 patients who were found to have less than 7 millimeters skin-to-cavity spacing. None of the patients suffered a serious skin reaction to the treatment.

The device requires very little spacing between the cavity and healthy tissue, versus other brachytherapy devices that require several millimeters. Accordingly, SAVI expands the number of women eligible for brachytherapy, compared to balloon devices.

The SAVI applicator is a recent advance in accelerated partial breast irradiation (APBI). This shortened course of high-dose radiation therapy is designed for early-stage breast cancer patients following lumpectomy surgery. Breast brachytherapy is a type of APBI in which radiation is delivered from within the breast. APBI reduces treatment time from six or seven weeks — which is generally required with conventional external beam, whole-breast irradiation — to just five days.

About 21st Century Oncology, Inc.

21st Century Oncology, Inc. is a leading developer and operator of radiation therapy centers. These centers, which are freestanding and hospital based, provide a full spectrum of radiation therapy services to cancer patients. In its more than 20 years of operation, the company has developed an operating model which enables the company’s centers to deliver high quality, cost effective patient care. Currently, the company operates more than 92 centers in 16 states, including Alabama, Arizona, California, Delaware, Florida, Kentucky, Maryland, Massachusetts, Michigan, New Jersey, New York, Nevada, North Carolina, Pennsylvania, Rhode Island and West Virginia. For more information, go to http://www.21stCenturyOncology.com

BTG plc (LSE:BGC), the life sciences company, announces that the full results of the US phase II safety study of Varisolve® are being presented today at the American College of Phlebology (ACP) 22nd Annual Congress. The results confirm that treatment with Varisolve® in subjects with right-to-left (R-L) cardiac shunts, which may allow residual bubbles following treatment to enter the cerebral arterial circulation, does not cause cerebral injury.

Principal investigator Kathleen Gibson, MD, of Lake Washington Vascular Surgeons, commented: “There is increasing interest in using foam sclerosant to treat varicose veins, because of the many benefits to patients including the speed of treatment and no requirement for general or tumescent anaesthesia. However, concerns have been raised relating to the potential risk of cerebral gas embolisation, particularly in patients who have a right-to-left cardiac shunt that may allow residual bubbles from the foam to enter the arterial circulation. This study found no evidence of any injury to the brain, retina or heart following treatment with the proprietary Varisolve® polidocanol microfoam in patients with cardiac shunts. These results should not be generalised to other foams, such as air-based foams that have high nitrogen content and are insoluble in blood.”

Louise Makin, chief executive officer of BTG, said: “It was very important for the future development and commercial potential of Varisolve® to demonstrate no subclinical effects following treatment in the brains of people with a cardiac shunt. Having removed this uncertainty, we have been able to press ahead with confidence both with partnering discussions and with the pilot phase III trials, in anticipation of the pivotal phase III trials that are planned to begin around mid-2009.”

Dr Gibson’s oral presentation,Proprietary Polidocanol Endovenous Microfoam Bubble Embolization Does Not Cause Cerebral Injury, will describe the multi-centre phase II safety study. Eligible patients were screened for the presence of a R-L shunt and if positive were given a baseline diffusion-weighted brain MRI scan. Patients were then treated with Varisolve® and monitored for 60 minutes following treatment using Transcranial Doppler (TCD) to detect bubbles entering the middle cerebral artery (MCA). Additional safety evaluations included blood oximetry, cardiac markers and electrocardiograms. Patients with detected MCA bubbles had follow-up diffusion-weighted brain MRI scans 24 hours and 28 days after treatment, neurological and visual field examinations plus other routine assessments. The study objective was to treat and follow up 50 patients with detected MCA bubbles.

Of 82 patients treated, 73% (60) had detection of MCA bubbles and all had at least one post-treatment MRI. No new MRI lesions or abnormal findings in the neurological and visual field examinations were detected in any patients, and none had any evidence of cardiac ischaemia.

Sapheno-femoral junction reflux was eliminated in 94% of patients at one month, and 88% had occlusion of the great saphenous vein. Adverse events were generally mild and transient and were consistent with previous experience with Varisolve®.

In a second oral presentation at ACP entitled Neurological and Visual Symptoms Following Treatment of the Saphenous Veins with Two Formulations of Polidocanol Endovenous Microfoam, Janet Rush, MD, BTG’s Head of US Regulatory & Medical Affairs, will describe the characteristics of the Varisolve® microfoam before and following its reformulation to minimise residual gas bubbles. Dr Rush will also compare clinical experience and results from studies of the original formulation (7% nitrogen) and the new formulation (0.01-0.8% nitrogen). She will conclude that of 534 patients treated with the original formulation, one patient (who had a cardiac shunt) had potentially clinically concerning neurological symptoms, while there have been no clinically concerning neurological or visual symptoms in any of the 106 patients treated with the new formulation.

A third oral presentation, by David Wright, MB, FRCS, BTG’s Vice President of Medical Affairs, entitled A Single-Center Pilot Study of Polidocanol Endovenous Microfoam (PEM) Treatment to Evaluate Presence and Durability of Gas Emboli Using Echocardiography, will explore the relative echocardiographic appearances of the original and new formulations of Varisolve®, with the objective of determining whether nitrogen ingress can “stabilise” small bubbles thereby causing them to persist in the circulatory system. Twenty patients were randomised to receive treatment with the original or new formulation of Varisolve®, and 10 additional patients were also randomised to pre-breathe oxygen or not. This was to explore whether pre-breathing oxygen would de-nitrogenate the blood sufficiently to prevent any stabilisation of the bubbles that might occur.

Dr Wright will conclude that all patients receiving endovenous microfoam ablation treatment have right sided cardiac bubbles. He will also conclude that the echocardiographic appearance is unaltered by elimination of nitrogen, and that pre-breathing with oxygen does not change the presence of bubbles. Treatment of the varicose veins was successful with all 35 patients (including 5 training patients) having occlusion of the great saphenous vein and elimination of reflux at 28 days.

In addition to the oral presentations, Gregory Suplick, BTG’s Vice President of Clinical Development, will present two poster presentations entitled Patient Recruitment Strategies and Referrals Associated with a Multicenter Phase II Study of Patients with GSV Incompetence and Patient Pre-Qualification Tools Used to Recruit Patients for a Multicenter Phase II Study of Patients with GSV Incompetence.

About BTG

BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka.

BTG