Medical Device Daily Contributing Writer

LOS ANGELES — The 49th annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO; Fairfax, Virginia), held here this week, enjoyed record attendance as its nearly 9,000 members are experiencing the benefits of an explosion in new technologies.Founded in 1958, ASTRO is the largest radiation oncology society in the world, its exhibit hall featuring a plethora of companies from both the pharmaceutical and device sides of this therapeutic world.

The meeting just follows the recent online release of heartening news from the National Cancer Institute of the National Institutes of Health. The death rate from cancer, which had been dropping by an average of 1.1% a year since 1993, has accelerated recently, to an average decrease of 2.1% a year from 2002 to 2004, the latest dates for which these statistics are available. Despite this decline, however, cancer remains, after heart disease, the second leading cause of death in the U.S., expected to total about 559,650 this year.But progress in improving cancer therapy is advancing on many fronts.

For breast cancer, less invasive breast conserving surgery (lumpectomy) and post-op accelerated partial breast irradiation (APBI) have made a significant impact.

APBI has been challenging whole breast, external beam radiation in the past several years for post-lumpectomy patients. Consistent with the growth of less invasive surgery in other surgical specialties, this trend is accelerating with the strong marketing and positive long-term data that has been released by industry pioneer Cytyc (Marlborough, Massachusetts). Cytyc, a leading player in the women’s health field, was acquired for $6.2 billion by Hologic (Bedford, Massachusetts) in late October (Medical Device Daily, Oct. 23, 2007).

The main advantage of APBI, also referred to as breast brachytherapy, is that it features a much shorter course of therapy than whole breast radiation (typically five days vs. six-to-eight weeks), with similarly low rates of cancer recurrence. Data from the American Cancer Society (Atlanta) indicates that there will be 178,000 new breast cancer cases diagnosed in the U.S. in 2007. Industry sources estimate that about 50% of these cancers are early stage and therefore are potential candidates for breast-conserving surgery and follow-up APBI.

According to a May 2007 research report written by Jason Mills, a medical device analyst at Canaccord Adams (Vancouver, Canada), the number of breast brachytherapy procedures in the U.S. will grow from an estimated 13,000 performed in 2006 to 47,000 performed in 2009, representing a torrid compound annual rate of 60%. Mills estimates the 2007 market for breast brachytherapy at $44 million, but puts the future market potential for this technology at around $350 million.

While the Hologic product, trade-named the MammoSite, currently dominates this category, several new competitors — with variations on the same theme of local, post-lumpectomy irradiation — are hoping to challenge its supremacy.

These contenders include SenoRx (Aliso Viejo, California), Xoft (Fremont, California), Cianna Medical (Aliso Viejo, California) and North American Scientific (NAS; Chatsworth, California). Each of these companies had prominent exhibits at ASTRO, and several held evening symposia.

NAS, which is a strong player in the prostate brachytherapy market with its palladium and iodine seed offerings, was one of the companies that held an informational evening meeting at ASTRO. The company’s new ClearPath HDR is similar in some respects to other APBI devices such as MammoSite.

However, with a design that features inner and outer multiple catheters, the company believes that it can expand the range of patients who can receive APBI. Therapeutic radiation dose can be distributed differentially to achieve full coverage of the treatment area, while sparing normal tissue.

At a NAS evening symposium, Rakesh Patel, MD, a prominent radiation oncologist practicing at the University of Wisconsin Medical School (Madison), gave a comprehensive and informative talk that he wryly titled “50 Ways to Irradiate the Breast.” After reviewing the pros and cons other APBI devices, Patel praised NAS’s product design, noting its improved features for improved patient comfort. He said that he favors this product “because it gives me the ability to achieve optimal radiation dosimetry.”

Peter Beitsch, MD, a surgical oncologist at the Dallas Surgical Group (Dallas, Texas), also spoke highly of the ClearPath, saying that the product would be a valued addition to the armamentaria of the breast surgeon and radiation oncologist, who “need to work together for the maximum benefit of the patient.”

Beitsch, a renowned breast cancer surgeon, has also noted in past ClearPath comments that “the ability to control the dose distribution should reduce toxicity to the skin and chest wall, decreasing complications and improving cosmesis.”

Supporting the positive comments of Beitsch and Patel, Adam Dickler, MD, a radiation oncologist from Rush University Medical Center (Chicago), presented a paper titled “A Dosimetric Comparison of MammoSite and ClearPath HDR Breast Brachytherapy Devices.” His conclusion was that “ClearPath HDR delivered, in every case, less radiation to normal tissue than MammoSite. Any decrease in the risk of normal tissue toxicity is significant for patients.”

NAS currently is selecting patients at five clinical sites, in order to fully validate the product’s capabilities. A full market launch is expected sometime in 2008. SenoRx is another prominent company addressing this market is SenoRx. Its Contura product, recently FDA-approved, is currently being utilized in select centers prior to a full launch in 2008.

This device features multiple offset lumens that provide dose-shaping opportunities to minimize the potential damage to adjacent skin and ribs. It also offers vacuum ports to enable the removal of air and accumulated seroma, which is a pocket of clear fluid that sometimes develops after breast surgery.

SenoRx already markets to the breast cancer surgeon with its flagship percutaneous Encor vacuum-assisted breast biopsy system. This affords the company a natural competitive advantage, as both breast cancer surgeons and radiation oncologists play a key role in post-lumpectomy, APBI device selection.

Just prior to ASTRO, Cianna Medical (formerly Biolucent) reported that it had treated 100 patients with its product, trade named SAVI. This device is also a single-entry, multi-catheter applicator.

All these new devices deliver radiation therapy locally as part of breast conservation therapy, an approach that is growing in popularity.