CE Mark for Abbott’s New Absorb GT1™ Stent System

Abbott has gained CE Mark approval for the latest advancement of its Absorb stent system, called Absorb GT1™. The company says the result is a combination of the world’s first fully dissolving stent with a next-generation delivery catheter to help doctors treat people with heart disease.

Background

Abbott is at the forefront of stent development, it’s Absorb line targeting the replacement of metallic stents by virtue of being more flexible and ultimately absorbable. The benefits of ultimate dissolution are that the stent-free vessel is free of a permanent implant, so has the potential to flex, pulse and dilate as a native vessel.

Built upon three generations of delivery catheter innovations, Absorb GT1 refers to the GlideTrack catheter, Abbott’s most advanced stent delivery system, which is designed to make it easier for doctors to access and treat diseased vessels in people with coronary artery disease (CAD). The GlideTrack catheter incorporates several design and technology changes that have the potential to improve deliverability and performance.

Last year, Abbott announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomized, controlled trial comparing the safety and effectiveness of the fully dissolving Absorb heart device to Abbott’s market-leading, metallic XIENCE family of drug eluting stents. At one year, overall clinical outcomes for Absorb were comparable to XIENCE. The trial, conducted primarily in Europe, included 501 people with CAD.

Abbott will be showing off its newly approved device at this year’s EuroPCR event in Paris.

Physician comments

“Absorb GT1 will enable physicians to treat more people with coronary artery disease due to its improved delivery system,” said Christoph Kurt Naber, director of Contilia Heart and Vascular Centre, Essen, Germany. “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.”

Company comments 

“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,” said Charles Simonton, M.D., FACC, FSCAI, chief medical officer and divisional vice president, Medical Affairs, vascular, Abbott. “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.”

Source: PR Newswire

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