Abbott announces positive results of its naturally dissolving stent
Posted: 2 September 2015 |
ABSORB Japan, a trial comparing the safety and effectiveness of Abbott’s fully dissolving Absorb heart stent to Xience, has produced positive results…
Abbott has announced positive one-year clinical results from ABSORB Japan, a multi-centre, randomised trial comparing the safety and effectiveness of Abbott’s fully dissolving Absorb™ heart stent to Xience®, Abbott’s market-leading, permanent drug eluting stent.
The trial was conducted in 38 sites in Japan and enrolled 400 people with coronary artery disease, the most common form of heart disease.
Absorb is a first-of-its-kind device that functions like a permanent, metallic stent by opening a blocked artery in the heart, restoring blood flow and providing relief from symptoms of coronary artery disease (CAD). However, unlike a metallic stent, which permanently restricts vessel movement and limits future treatment options, Absorb is made of a naturally dissolvable material that leaves behind a restored vessel free of a permanent implant, with the potential to flex, pulse and dilate in response to various demands on the heart, based on people’s lifestyle and activities.
Fully dissolving heart stents are the next evolution in percutaneous coronary intervention
“The results of the ABSORB Japan study continue to affirm that Absorb shows strong performance near-term and preserves the vessel for potential future procedures,” said Takeshi Kimura, M.D., Ph.D., director, Department of Cardiovascular Medicine, Kyoto University Hospital, Japan, and principal investigator of the ABSORB Japan study. “Fully dissolving heart stents are the next evolution in percutaneous coronary intervention and are designed to leave nothing behind in the body, thus restoring the vessel more naturally over time, which cannot be achieved with a permanent drug eluting stent.”
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 Absorb to Xience. At one year, overall clinical outcomes for Absorb were comparable to Xience. The trial, conducted primarily in Europe, included 501 people with CAD.
“The ABSORB Japan results contribute to the growing body of Absorb data, providing further clinical evidence that the fully dissolving stent initially functions like a permanent, metallic stent by opening up blocked heart vessels and restoring blood flow. However, unlike a metallic drug eluting stent, Absorb naturally dissolves over time, leaving nothing behind,” said Charles Simonton, M.D., FACC, FSCAI, chief medical officer and divisional vice president, Medical Affairs, vascular, Abbott. “The fact that Absorb completely dissolves means that the restored vessel has the potential to move as it needs to, based on lifestyle activities.”
Absorb is available in more than 90 countries worldwide. Abbott has completed its submission for regulatory approval of Absorb in the United States and Japan. ABSORB Japan is designed to support regulatory approval of Absorb in Japan.