Abbott (NYSE:ABT) said today that it won CE Mark approval in the European Union for a next-generation delivery device for its Absorb bioabsorbable coronary stent.
The Absorb GT1 is the latest development for Abbott’s Absorb device, which is designed to completely dissolve after implantation.
The GT1 upgrade consists of an updated delivery catheter, which Abbott said incorporates several improvements.
"Absorb GT1 will enable physicians to treat more people with coronary artery disease due to its improved delivery system. Dissolving stents are the next logical step in the treatment of patients with coronary artery disease as these stents completely dissolve after opening up clogged arteries and restoring blood flow. With the prevalence of CAD around the world, this therapy has the potential to improve the health of many people," Dr. Christoph Kurt Naber, of the Essen, Germany, Contilia Heart & Vascular Centre, said in prepared remarks.
An Abbott spokesman told MassDevice.com today that Abbott is on track for Absorb approvals in China and Japan, where the company is running clinical trials, and expects to seek a nod from the FDA later this year (there are roughly 2,000 patients enrolled in a U.S. trial). Results from Abbott’s Absorb III pivotal trial are due to be presented later this year at the Transcatheter Cardiovascular Therapeutics conference in San Francisco, he wrote in an email.
Results from the 501-patient Absorb II study, which Abbott billed as the world’s 1st prospective, randomized, controlled trial comparing absorbable stents to their bare-metal forebears, are slated to be revealed at the EuroPCR conference in Paris this week, Abbott said.
"Coronary artery disease is the most common disease in developed countries, and the new Absorb GT1 catheter delivery system may improve the ability of doctors to treat more people with CAD by opening up coronary blockages in hard-to-reach areas with this novel, fully dissolving stent. Abbott is committed to developing scientific and technological innovations that help people regain their health and get back to their lives, and this latest Absorb advancement will allow more people to benefit from this breakthrough medical technology," vice president Dr. Charles Simonton said in a press release.