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Boston Scientific Gets European Approval for the REBEL: a "New" Bare Metal Stent
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Boston Scientific's REBEL bare metal stent |
March 17, 2014 -- Take away the everolimus-eluting polymer from Boston Scientific's FDA-approved Promus PREMIER™
stent and what do you have? The REBEL bare metal stent, which just received CE Mark approval last week and is now available for the European market.
REBEL is probably a good name for this device, in that it "rebels" against the historical norm, wherein a bare metal stent platform first gets approved for safety and efficacy, and only then gets coated with a drug-eluting polymer, is tested in clinical trials, gets CE Mark approval and finally FDA approval.
The Promus PREMIER already achieved the coveted FDA seal of approval last November, so the announcement of this new bare metal stent may seem anticlimactic, except that there is still a market for non-drug-coated stents. There are instances when, for one reason or another, a patient is not an ideal candidate for a drug-eluting stent (DES): perhaps they cannot tolerate the recommended 6-12 month course of dual antiplatelet therapy (DAPT), or are in need of surgery in the very near future, which would require DAPT cessation, or their physician feels they are potentially too thrombogenic for a DES, possibly in the setting of STEMI.
Interestingly, all of these situations that have historically favored the use of bare metal stents have been tested in recent clinical trials, and the downsides of DES have been shown to be minimal, even non-existent. While not recommended, it's been demonstrated that, for example with Medtronic's Resolute, there is no increase in stent thrombosis if DAPT has to be stopped after one month. It's also been shown that, over time, a DES has superior outcomes to BMS in terms of both restenosis and stent thrombosis.
The fears around DES adverse events date back to 2006, when data was revealed that the first generation DES in fact did show low frequency but serious adverse outcomes in some patients. The initial enthusiasm for DES was immediately tempered and many cardiologists decided to continue using bare metal stents for specific cases. With the advent of second, third and now fourth generation drug-eluting stents, any advantage that bare metal stents had over DES in these specific clinical situations has been minimized.
One of the major advantages of the Rebel stent, shared by its drug-eluting cousin, is that it contains a significant amount of platinum, which makes it highly visible under fluoroscopy. But whether or not bare metal stents will capture more of the device market than they currently enjoy is yet to be seen.
The press release from Boston Scientific follows:
Boston Scientific Receives CE Mark Approval for REBEL™ Platinum Chromium Coronary Stent System
Newest Bare Metal Stent Technology Features Advanced Architecture and Provides Physicians with Enhanced Treatment Option for Patients
March 12, 2014 -- Natick, Massachusetts -- Continuing to advance leading stent technology, Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company's latest generation bare metal stent for the treatment of coronary artery disease (CAD).
Developed to expand the Boston Scientific platinum chromium customized architecture family of stents, the REBEL Stent System offers physicians the same stent platform as the Promus PREMIER™ Drug Eluting Stent (DES) but without the Everolimus drug. Bare metal stents continue to play an important role in the treatment of coronary artery disease and represent a significant portion of the global stent market.
"I am glad to have a bare metal stent that performs like the PREMIER DES but allows me to treat patients who are not candidates for DES therapy," said Prof. Didier Carrie, M.D., Ph.D., an investigator for the OMEGA clinical trial at Centre Hopital Universitaire, Rangueil, France. "In addition to its great visibility and deliverability, the platinum chromium stent architecture features low recoil that is particularly important for patients treated with bare metal stents."
The REBEL Stent System features unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, while improving axial strength and deliverability. Its enhanced low-profile delivery system also features a shorter, more visible tip, a dual-layer balloon and a Bi-Segment™ inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.
CAD is a narrowing of blood vessels that supply blood and oxygen to the heart. Patients with CAD may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. A primary treatment for CAD is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.
"Boston Scientific is committed to advancing cardiology and providing the best treatment options for all patients with coronary artery disease," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "This includes innovating and improving the performance of bare metal stent technology to enhance patient outcomes."
The REBEL Stent System is offered in a matrix of 48 sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm on a Monorail™ platform. This provides physicians with a range of options designed to best suit patient needs.
Data from the OMEGA clinical trial evaluating the Platinum Chromium Bare Metal Stent System were presented in February by John C. Wang, M.D., Medstar Union Memorial Hospital, Baltimore, Md. at the Cardiovascular Research Technologies conference in Washington, D.C. OMEGA is a single arm, multi-center trial in the U.S. and Europe. OMEGA trial data are expected to support a U.S. FDA regulatory submission.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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Reported by Burt Cohen, March 17, 2014
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