Boston Scientific (Marlborough, MA) announced on Monday that it has received FDA approval for its Synergy Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease. It is the first and only BP-DES approved for use in the United States, entering a domestic stent market that is valued at $1.3 billion annually; globally, the market is worth $4 billion. The product received the CE mark in 2012, and has been available in the European Union and other countries that recognize the marking since then.
The Synergy stent is designed to prop open clogged arteries and deliver a drug to prevent the arteries from renarrowing. Following elution of the drug, the polymer is absorbed into the body. The technology enables more rapid and complete arterial healing, and thereby reduces the risk of complications associated with long-term polymer exposure compared to currently used drug-eluting stents (DES) with permanent polymers, according to Boston Scientific.
Existing DES devices reduce coronary restenosis, but the polymer remains on the stent after the drug is delivered. Long-term exposure to the polymer may cause inflammation, which delays healing and has been associated with complications, including neoatherosclerosis and stent thrombosis, writes Boston Scientific in a news release. The Synergy stent is designed for faster and sustained healing by eliminating long-term polymer exposure, adds the medical device company.
Data from the EVOLVE II trial, which Boston Scientific claims included the most complex patient population ever studied in a U.S. regulatory approval stent trial, demonstrated exceptional performance and safety of the Synergy stent, said Dean Kereiakes, MD, principal investigator of the clinical trial and Medical Director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati. "The U.S. cardiology community will have access to a bioabsorbable polymer DES which will provide excellent clinical outcomes and should optimize vessel healing," said Kereiakes.
While the Synergy stent is the first bioresorbable polymer stent, the first fully absorbable stent is Abbott Vascular's Absorb, notes Arundhati Parmar in PlasticToday's sister publication MD+DI. "That device is fully absorbed into the body between two and three years and doesn't leave anything behind, explained a spokesman to Parmar. It is awaiting FDA approval but is approved overseas.