The US Food and Drug Administration (FDA) has granted approval for Boston Scientific‘s Synergy bioabsorbable polymer drug-eluting stent system (BP-DES) to treat coronary artery disease (CAD).
With the approval, the company will start commercialisation of the first and only BP-DES, which offers synchronised drug and polymer absorption, in the US.
Compared to currently used drug-eluting stents (DES) with permanent polymers, the Synergy system is designed to provide more rapid and complete arterial healing, as well as reduce the risk of complications associated with long-term polymer exposure.
Existing DES devices reduce coronary restenosis, but polymer remains on the stent after the drug is delivered and long-term exposure to polymer may cause inflammation, which delays healing and has been associated with complications, including neoatherosclerosis and stent thrombosis.
The company noted that Synergy stent is designed for faster and sustained healing by reducing long-term polymer exposure.
Principal investigator of the EVOLVE II trial Dean Kereiakes said: "Data from the EVOLVE II trial, which included the most complex patient population studied in a US regulatory approval stent trial, demonstrated exceptional performance and safety of the Synergy stent.
"The US cardiology community will have access to a bioabsorbable polymer DES, which will provide excellent clinical outcomes and should optimise vessel healing."
Synergy is a bioabsorbable polymer stent, which features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at three months.
The Synergy system’s Evolve II trial showed 0% definite stent thrombosis (ST) after 24 hours, while four year Evolve trial data showed a continued 0% stent thrombosis rate and a very low target lesion revascularisation (TLR) rate of 1.1%.
Boston Scientific interventional cardiology president Kevin Ballinger said: "The introduction of the first bioabsorbable polymer stent in the US is a tremendous milestone in the evolution of stent technology.
"The Synergy stent is a next generation therapy designed to improve patient outcomes and ultimately reduce healthcare costs associated with the treatment of coronary artery disease."
The company also received FDA investigational device exemption (IDE) approval for the Evolve short dual anti-platelet therapy (DAPT) study of Synergy stent, which is expected to start in the first quarter of next year.
The trial was designed to evaluate the safety of three month use of DAPT in patients at high risk of bleeding when undergoing percutaneous coronary intervention (PCI) with the Synergy stent.
Image: Boston gets FDA approval for Synergy stent system to treat CAD. Photo: courtesy of Boston Scientific Corporation.