Article preview reprinted from IN VIVO - September/October, 2009
IN VIVO -- Proponents of cardiac resynchronization devices with a defibrillation function expect the recently released results of the MADIT-CRT trial to give a long-awaited boost to the overall implantable cardioverter defibrillator market. Boston Scientific Corp., the sponsor of the study, expects the FDA to soon expand the indication for its CRT devices to the roughly 70% of heart failure patients worldwide in New York Heart Association heart failure Class I or Class II, reflecting the improvements in hospitalization and ventricular output linked to CRT in the trial. Read more...
MADIT-CRT: Good News for Devices in Heart Failure, But Will Referring Physicians Care?
Article preview reprinted from IN VIVO - September/October, 2009
Proponents of cardiac resynchronization devices with a defibrillation function (CRT-D) expect the recently released results of the MADIT-CRT trial to give a long-awaited boost to the overall implantable cardioverter defibrillator market, because they offer patients a chance to feel better, instead of just living longer. Boston Scientific Corp., the sponsor of the study, expects the FDA to soon expand the indication for its CRT devices to the roughly 70% of heart failure patients worldwide--about 22 million patients--in New York Heart Association heart failure Class I or Class II, reflecting the improvements in hospitalization and ventricular output linked to CRT in the trial. (See sidebar, "MADIT-CRT Shows Resynch Therapy Slows Early Heart Failure.")
The company projects the new indication could expand the defibrillator market by as much as $250 million in the US over the next three years, and $400 to $500 million worldwide. Much of the gain is expected to come from a shift in the mix of the overall ICD/CRT-D market to more CRT-D devices, which cost $7,000 to $8,000 more than regular ICDs. "MADIT-CRT holds the promise to become the gold standard for treatment of heart failure patients," Boston Scientific cardiac rhythm management group president Fred Colen told analysts and investors after the study results were disclosed on September 1.
MADIT-CRT primary investigator Arthur Moss, MD, University of Rochester Medical Center, suggests that MADIT-CRT shows that CRT-D devices are a "true preventative therapy. We inhibited the development--or if you want to use the word 'progression'--of heart failure in at-risk cardiac patients. This, for the first time, changes the role for device therapy as a preventative therapy and that's really a very, very important consideration."
Boston Scientific's competitors in the CRT space also expect to eventually take advantage of Boston Scientific's investment in the trial. Mark Carlson, MD, St. Jude Medical .'s chief medical officer and SVP of clinical affairs for the cardiac rhythm management division, says, "We're very optimistic about the future opportunities for CRT based on the MADIT-CRT results and the evidence that now exists for the benefit of this therapy for Class I and II heart failure patients. We think it's positive for the [ICD] market and that most likely we'll see a shift in the mix toward CRT devices."
Medtronic Inc. is taking advantage of the MADIT-CRT announcement to highlight some of its own CRT research. Medical director of Medtronic's cardiac rhythm disease management business David Steinhaus, MD, points out that MADIT-CRT reinforces the results of his company's REVERSE study, first announced last spring. REVERSE did not meet statistical significance for its primary end point at one year, but the 24-month follow-up shows a 62% reduction in risk of first heart failure hospitalizations or death.
While they will trail Boston Scientific in earning an FDA indication for Class I and II patients, St. Jude and Medtronic hope to take advantage of any increased demand for CRT devices in heart failure patients with a continuous series of enhancements to their devices intended to make their products more attractive to the implanting physicians for treating heart failure patients. For example, Medtronic's CRT-D and ICD devices feature the OptiVol impedance monitoring function for detecting fluid buildups in the chest that precede a heart failure decompensation event. And St. Jude, which is also developing an intrathoracic fluid-monitoring capability for its devices, will soon launch new leads and connectors that make it easier to implant its device.
Purchase this article online as a PDF and receive it immediately via email. Questions? Call (800) 332-2181. 100% Satisfaction Guaranteed. Subscribe to IN VIVO.
Single-incision laparoscopy or natural orifice surgery: Which will win the day, or is there room for both? Find out in the NEW 48-Page SPECIAL REPORT from Medtech Insight: "Fulfilling the Promise of the Scarless Surgery Revolution -- When will breakthrough endoscopic technologies hit prime time?" Find out more...
Companies mentioned in this article:
University of Rochester Medical Center
IN VIVO delivers:
- Revealing, in-depth coverage of your competitors' strategies
- Incisive projections of future industry trends and their implications for your business
- Expert analysis of key industry developments
- Exclusive interviews with top industry executives and analysts
- In-depth examination of dealmaking, marketing, R&D, regulatory, and finance strategies -- those that were successful and those that missed the mark
Comments