Abbott announces CE mark for advancement of Absorb stent system for heart disease

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Abbott has received CE mark for the latest advancement of its Absorb stent system—Absorb GT1— which combines the fully dissolving stent with a next-generation delivery catheter to help doctors treat people with heart disease.

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). A company press release states that the GlideTrack catheter incorporates several design and technology changes that have the potential to improve deliverability and performance.

“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.”

Last year, Abbott announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomised, 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. At EuroPCR 2015 (19­–22 May, Paris, France), Absorb data was presented throughout the conference. 

“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, chief medical officer and divisional vice president, Medical Affairs, vascular, Abbott.

Absorb is currently available in more than 70 countries worldwide. The company recently completed its submission for regulatory approval of Absorb in Japan, and it plans to submit reports, including data from pivotal trials, for regulatory approvals in the USA and China in the coming months. Combined, these three countries represent more than 50% of the world’s heart stent procedures. Currently, Absorb is an investigational device in the USA and is not approved for commercial use.