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Boston Scientific Gets FDA Approval for REBEL Bare Metal Stent
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Boston Scientific's REBEL bare metal stent |
July 26, 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 FDA approval. The REBEL had gained European CE Mark approval in March.
As previously noted, REBEL is a good name for this device, because it "rebels" against the 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.
Why Choose a Bare Metal Stent?
The Promus PREMIER already achieved FDA 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, patients are not ideal candidates for drug-eluting stents (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.
Does the Bare Metal Stent Still Offer Advantages?
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 officially 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.
Additionally it's been shown that, over time, the newer generation of DES has superior outcomes to BMS in terms of both restenosis and stent thrombosis. The recently reported ZEUS trial, which studied the Endeavor stent, confirmed these findings and lead author, Dr. Marco Valgimigli told Angioplasty.Org, "the implications of our study and one of the conclusions that was reached at least among us...is that probably bare metal stents have no reason to be existing on the market anymore."
Concern Over DES Late Stent Thrombosis Is Historical
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, specifically an increased risk of late stent thrombosis, a clotting of the blood inside the stent, causing blockage of flow and often a heart attack. The initial enthusiasm for DES was immediately tempered and many cardiologists decided to continue using bare metal stents for specific cases. However, 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 FDA Approval for REBEL™ Platinum Chromium Coronary Stent System
Advanced Bare-Metal Stent Provides Additional Treatment Option for Interventional Cardiologists and Patients
July 21, 2014 -- Marlborough, Massachusetts -- Boston Scientific Corporation (NYSE: BSX) has received FDA 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). Bare-metal stents continue to play an important role in the treatment of CAD and represent a significant portion of the global stent market. The company announced CE Mark for the REBEL Stent System in February. The REBEL Stent System expands the Boston Scientific family of stents featuring its proprietary platinum chromium (PtCr) alloy and a customized stent architecture design. The REBEL Stent offers the identical stent platform as the Promus PREMIER™ Drug-Eluting Stent (DES) but without the Everolimus drug.
"Bare-metal stents are an important part of our practice, as not every patient can receive a drug-eluting stent. This new bare-metal stent has the same great visibility and deliverability as the PREMIER DES but allows me to treat patients who are not candidates for DES therapy," said John C. Wang, M.D., of Medstar Union Memorial Hospital, Baltimore, Md. "In addition, the platinum chromium architecture provides great radial strength with low recoil, which is particularly important in patients receiving 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.
"Boston Scientific is committed to developing the best treatment options for all patients with coronary artery disease," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "Launching the REBEL Stent System in the U.S. is another important step to ensure that we offer physicians the most differentiated and broadest product portfolio possible."
Of note, Dr. Wang presented data from the OMEGA clinical trial evaluating the REBEL Stent System in February at the Cardiovascular Research Technologies conference in Washington, D.C. OMEGA is a single arm, multi-center trial in the U.S. and Europe and the first reported results showed low event rates at nine months.
The REBEL Stent System is offered in a matrix of 46 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.
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, July 26, 2014 (portions adapted from March 17, 2014 article) |
