Abbott announced today that the U.S. Food and Drug Administration has approved the company’s Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.
Absorb is the only fully dissolving stent approved for the treatment of coronary artery disease, which affects 15 million people in the United States and remains a leading cause of death worldwide, despite decades of therapeutic advances. While stents are traditionally made of metal, Abbott’s Absorb stent is made of a naturally dissolving material, similar to dissolving sutures. Absorb disappears completely in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.
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Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease.
With this FDA approval, Boston Scientific will commence commercialization of the first and only BP-DES in the U.S. Notably, both the drug coating and the polymer – which modulates drug release – are fully absorbed shortly after drug elution is complete at three months.
The SYNERGY Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers.
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OhioHealth Riverside Methodist Hospital is now treating patients with peripheral artery disease (PAD) with the first drug-eluting stent to be used outside of the heart. Cook Medical’s Zilver PTX is a drug-coated stent that is used to reopen a long thigh artery, located above the knee (the femoropopliteal artery), narrowed or blocked due to PAD. This is the most common artery for PAD blockages.
To view Multimedia News Release, go to http://www.multivu.com/mnr/60291-ohiohealth-riverside-hospital-zilver-ptx-drug-coated-stent-for-pad
Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced FDA 510(k) clearance has been granted for the CorPath 200 System to be used in percutaneous coronary interventions (PCI). The technology is now approved in the United States to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with coronary artery disease (CAD).
“We are pleased to have received clearance from the FDA for the world’s first system designed for robotic-assisted PCI procedures,” said David M. Handler, President and CEO of Corindus Vascular Robotics. “This is an important milestone for interventional cardiology as we take the next step in transforming the way these procedures are performed in the future. The CorPath System offers hospitals the opportunity to bring robotic-assisted technology benefits to their coronary patients and their physicians.”
To view Multimedia News Release, go to http://www.multivu.com/mnr/57343-corindus-vascular-robotics-wins-fda-510k-clearance-for-corpath-200-system
Boston Scientific Corporation (NYSE:BSX) announces U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the Company’s next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug. The Company plans to begin marketing the product in the U.S. immediately.
To view Multimedia News Release, go to http://www.multivu.com/mnr/43510-boston-scientific-fda-promus-element-plus-platinum-chromium-stent-system
C. R. Bard, Inc. today announced the publication of RESILIENT trial results by Circulation: Cardiovascular Interventions showing the Bard LifeStent® Vascular Stent improved patency and reduced revascularization rates in patients with moderate-length lesions in the superficial femoral artery (SFA) and proximal popliteal artery compared to patients treated with percutaneous transluminal angioplasty (PTA).
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/bard/44623/