Abbott (NYSE:ABT) said today it won FDA premarket approval for its Absorb bioresorbable everolimus eluting heart stent, touting it as the 1st fully dissolving stent approved for treating coronary artery disease.
The newly cleared stent is designed to dissolve completely after approximately 3 years after serving to keep clogged arteries open and promote healing in the treated artery segment, Abbott said.
“The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease. This novel technology appeals to both physicians and patients alike because after treating the underlying blockage it is completely absorbed, leaving nothing behind. No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient’s future,” Absorb clinical trial chair Dr. Gregg Stone of the Columbia University Medical Center said in a press release.
The company said it plans to launch the Absorb device at U.S. hospitals, starting with the interventional cardiology centers that participated in Absorb clinical trials.
“Abbott’s goal is to help people everywhere live better, fuller and healthier lives. The Absorb bioresorbable stent treats coronary artery disease without committing people to a permanent metal implant—giving them peace of mind and helping them get back to their daily lives without the concern of having a permanent metallic implant. We’re very excited to bring the promise of Absorb to patients in the United States,” vascular senior veep Deepak Nath said in prepared remarks.
The Absorb is set to compete with Medtronic‘s (NYSE:MDT) Resolute stent and Boston Scientific‘s (NYSE:BSX) Synergy and Promus stents. Synergy’s polymer coating used to deliver a drug disappears over time, leaving a bare-metal stent in place.
“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent,” FDA Center for Devices and Radiological Health cardiovascular device division director Dr. Bram Zuckerman said in a prepared statement.
In March, an FDA advisory panel recommended approval for Abbott’s Absorb bioresorbable stent. The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-0, with one abstention, on the risk-benefit profile for the Absorb device.
The Absorb GT1 landed CE Mark approval in the European Union in May 2015. The Absorb stent met the primary endpoint in a Phase III pivotal trial, researchers announced last October at the annual Transcatheter Cardiovascular Therapeutics conference.
Abbott has said it’s on track for Absorb approvals in China and Japan.
