Dive Brief:
- The FDA has enlisted an outside expert panel to review data regarding Abbott Laboratories' unique dissolving heart stent, Absorb, for potential approval.
- The company is seeking approval for use of the device as an alternative to permanent, metal stents used to keep arteries open once a blockage has been removed.
- However, the safety of the Absorb stent is questionable due to higher cardiovascular complications compared to the older stents and when used in smaller arteries.
Dive Insight:
The Absorb stent releases medication for a year and then slowly dissolves over two years. Companies began to coat metal stents in 2003 to prevent arteries from re-clogging but research showed treated arteries could still potentially develop blood clots and trigger heart attacks. Abbott's Absorb data submitted to the FDA did show a higher complication rate of 7.8% versus its older metal stent at 6.1%. Although not statistically significant, the agency will ask the panel if it has safety implications for the device.
Also, since the Absorb stent has higher complications in smaller blood vessels, the agency wants the panel to determine whether the company's proposed warning to cardiologists not to use it in vessels under a certain size is sufficient.
Lawrence Biegelsen, a Wells Fargo analyst, told Modern Healthcare he thinks the FDA will approve the device but due to its drawbacks, it will only capture 5% of the U.S. stent market. ABC News reported that 850,000 Americans receive heart stents every year. Absorb is already being sold in Europe.
According to FierceMedicalDevices, market research company GlobalData predicted the bioresorbable stent market to reach $319 million in sales in the U.S. by 2018. These stents average between $3,000 to $4,000 - twice the cost of a drug-releasing stent.