18 Mar Panel Recommends Approval of Dissolvable Stent
On Tuesday, federal health advisers overwhelmingly backed the safety and effectiveness of an experimental medical implant — a dissolvable stent — that dissolves into the body after doing its job.
Currently available stents are tiny, mesh-wire tubes used to prop open blood vessels that have narrowed and result in heart attacks or angina. Current stents are made of high-grade stainless steel or other metal alloys and remain in the body permanently. Many of the newer stents are coated with a medication to prevent excessive scar tissue build-up on these metal scaffolds and are called drug-eluting stents.
The new implant, called Absorb, is made of degradable material that’s designed to stay intact for a year before gradually breaking down over the following two years. Abbott Laboratories has asked the FDA to approve its absorbable stent as an alternative to permanent, metal implants.
A panel of Food and Drug Administration advisers voted unanimously that the Absorb heart stent is effective and safe for treating patients with narrowing arteries.
Longer-term studies would still be required to understand the implications and duration for medications required to keep these stents open (i.e. anti-platelet medications), ability to keep vessels open over time as well as use of these stents in various complex vessel anatomy.
The CardioVisual app allows professionals and patients to visualize how stents are deployed along with a long list of newer devices that are used to treat various heart blockages.