Like every year, the 2010 American Society for Radiation Oncology (ASTRO) annual meeting includes an immense amount of new material, covering everything from new technologies to new clinical trials. This year, however, there's a different feeling in the air. While it's clearly not a new theme, there is unquestionably a renewed focus on safety and evidence-based medicine. Looking back a few months, everyone can recall the (now not so recent) New York Times series on errors in radiation therapy. As the topic has become elevated in our minds and the field of radiation oncology has been delivered a sobering update, ASTRO has responded in kind with a meeting agenda largely devoted to supporting providers in improving clinical care.
Kicking of the meeting this morning, the Presidential Symposium set the tenor with a notable focus on safety in radiation practices, as well as scrutiny of new devices and approaches. Split into three sections, the symposium was focused on the following: practicing evidence-based radiation oncology, scrutinizing the value of new technologies and modalities (the session was called "Technology Assessment: Beyond the Cool Gizmo"), and a sharp focus on quality, performance, and safety. While change clearly can't occur overnight, ASTRO has started by providing some specific tools for programs and providers to improve safety on a day to day basis. As the broader healthcare field faces a great deal of potential change with reform, the national themes have clearly influenced the focus of this meeting.
Looking toward the next few days, there's much more to come around each of these issues, so stay tuned for updates on each. Especially as we make our rounds on the vendor floor, it will be interesting to see the intersection of these seemingly conservative themes with the innovation brought by the industry sector. At first glace, there are quite a few notable developments this year, so look forward to updates on these developments and technologies, as well.
It's been an active fall for dialog around the use of vertebroplasty and kyphoplasty in the treatment of vertebral compression fractures (VCFs). As covered in the Pipleline previously, we've seen guidelines issued against the procedures, new products enter the market, and clinicians at the annual North American Spine Society (NASS) rise to the defense of these controversial procedures. The latest developments in this dynamic area has been questions about reimbursement.
Questions of Reimbursement Enter Vertebroplasty and Kyphoplasty Debate
After months of speculation, on Friday, October 15th, Medtronic finally announced that it had received investigational device approval (IDE) from the FDA to launch a pivotal U.S. trial of its CoreValve System for transcatheter aortic valve implantation (TAVI). After Medtronic's purchase of the CoreValve System last February, the cardiovascular community has been anticipating a U.S. trial to bring CoreValve to the U.S. market. The CoreValve System offers a minimally invasive, interventional alternative to traditional surgical valve replacement in patients with aortic stenosis. This announcement comes on the heels of the recent presentation of Edwards LifeScience's year-one trial results of its transcatheter aortic valve, the SAPIEN, at the Transcatheter Therapeutics Conference (TCT) in September. Although both devices are commercially available in Europe, the SAPIEN is currently at an advantage in the U.S. as its pivotal FDA PARTNER trial is nearing completion.
Spanning 40 U.S. sites, Medtronic's trial will study over 1,200 patients in two concurrent studies. Like the PARTNER trial, it will evaluate the efficacy and safety of a minimally invasive approach to treating patients with severe aortic stenosis who are at high-risk or deemed ineligible for traditional open surgery. Patients will then be separated into two cohorts: high-risk patients randomized to TAVI with the CoreValve System or open surgery and inoperable patients randomized to TAVI or optimal medical management.
The CoreValve System is a self-expandable valve delivered via an 18-french delivery system, typically transfemorally through a patient's groin. At TCT, principal investigator, Dr. Jeffrey Popma, an interventional cardiologist at Beth Israel Deaconess Medical Center, reported that the 40 unannounced trial sites were undergoing training on implantation techniques. Although, thus far, it remains unclear whether Medtronic will require these trial sites to perform procedures in a hybrid operating room, industry experts emphasize that a hybrid facility is the optimal environment for CoreValve System implantation. To date, however, the System has been implanted in over 12,000 patients worldwide, with a sizable percentage of procedures taking place in standard cath facilities.
The CoreValve's trial launch marks the company's official entrance into the U.S. transcatheter valve arena and thus represents an important milestone in the journey toward the CoreValve device's commercial availability. This announcement is only the beginning for Medtronic, however, as Edward's SAPIEN will likely receive commercial approval around late 2011, a deadline that Medtronic will be pushing towards for full trial enrollment.