With heart disease being the leading cause of death for men and women around the world, and coronary artery disease the most common type of heart disease, dissolving stents have the potential to affect a lot of patients and make a lot of money, so an announcement from the global company Abbott today is big news.
Coronary artery disease occurs when arteries that supply blood to the heart become narrowed or blocked due to plaque buildup, leading to chest pain or shortness of breath and increased risk of heart attack. In the past these problems were addressed through bypass surgery. In recent years metal shunts that keep the arteries open have become the go to treatment. That may change again.
Experts seem to agree that bioresorbable stents will eventually replace conventional metallic stents in the coming years. Most bioresorbable stents are made of polylactic acid, a naturally dissolvable material that is used in medical implants such as dissolving sutures. However, the advantage of not implanting a permanent metal prosthesis is the elimination of the cause of potential inflammation that can lead to late-stent thrombosis and restenosis. An additional benefit is that once the stent dissolves after about two years, it restores the vessel to a natural state of vasoconstriction and vasodilatation. The disappearance of the device also leaves open all options if future interventions are needed.
Right now dissolving stents do have some drawbacks compared to metallic stents, their polymer material can recoil after expansion, stent thickness can cause maneuverability and crossing issues, difficulty visualizing a non-metallic stent on fluoroscopy and stents not crimping firmly on delivery balloons. But as the technology continues to advance, these issues may be resolved. Even if they are not, experts say growing clinical data shows the benefits of bioresorbable stents may outweigh any drawbacks.
There are at least 15 bioresorbable stent programs in progress, with five in the advanced development stages and two having received European CE mark approval, said Alexandre Abizaid, M.D., Ph.D., FACC, director of cardiology, Dante Pazzanese Hospital, Sao Paulo, Brazil, at the American College of Cardiology (ACC) meetings in September 2014. The first to be released on the commercial market outside the United States was the Abbott Vascular Bioresorbable Vascular Scaffold (BVS), also known as the Absorb stent.
By far the BVS has the most clinical experience, with more than 13,000 patients around the world having been treated with the device. The BVS is a drug-eluting stent (DES), delivering everolimus. It gained European CE mark in 2011.
Continuing their successes Abbott announced today positive one-year clinical results from ABSORB Japan, a multi-center, randomized 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 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.”
“At the end of the day, we have shown that in this patient population and in this trial, Absorb is performing as well as Xience, and Xience was very good,” said Abbott Laboratories Executive Vice President of Medical Devices John Capek after last fall’s success in Europe. “Perhaps we are seeing what was reported to be some of the benefits of Absorb, even at one year — a more patient-friendly implant that has the opportunity to reduce angina.”
“The excitement about a heart device that dissolves after doing its job will continue to increase with these positive results from a randomized, controlled trial showing comparable outcomes between Absorb and XIENCE,” said Charles Simonton, Abbott Vascular chief medical officer in an interview last year.
Currently, Absorb is available in more than 90 countries worldwide and they are actively pursuing further expansion. 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. At the 2015 Transcatheter Cardiovascular Therapeutics (TCT) conference in October, Abbott will present one-year pivotal data from ABSORB III and ABSORB China at late-breaking sessions, as well as two-year data from ABSORB II.
There are a few companies hot on the heels of Abbott. In May 2014, Elixir Medical received European CE mark approval for its DESolve 100 novolimus-eluting bioresorbable coronary stent. It offers a scaffold with a thinner strut profile of 100 microns, which is smaller than the BVS at about 150 microns. DESolve is designed to degrade within one year.
Other companies developing bioresorbable stent technologies include Biotronik, Kyoto Medical Planning, Micell Technologies and Reva Medical. Terumo purchased Arterial Remodeling Technologies in March, which is developing a drug-eluting bioresorbable scaffold for the coronary arteries. Boston Scientific made a major investment in January in Amaranth Medical, which is seeking European approval for the Fortitude drug-eluting bioresorbable stent. Funding will support development of the next-generation Fortitude with thinner struts.
With the market for technologies and products in the treatment of coronary artery disease forecasted to grow from $12.2 billion in 2014 to $22.5 billion in 2021, according to a new study from Smithers Apex, all of these advances bear close watching.
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