This article is more than 5 years old. Information may no longer be current.
Abbott to cease sales of bioresorbable vascular scaffold
Click Here to Manage Email Alerts
Abbott announced it will stop selling its first-generation bioresorbable vascular scaffold in all countries “due to low commercial sales,” according to an update on the company website.
The company will discontinue all sizes of the Absorb Bioresorbable Vascular Scaffold System and the Absorb GT1 Bioresorbable Vascular Scaffold System by Sept. 14.
In the announcement on the Abbott website, the company stated that the product is discontinued because of low commercial sales, but development on future generations of the device will proceed.
“We pioneered bioresorbable technology because we believe it offers patients the possibility of life without permanent metallic implants, and we will continue work on a next-generation bioresorbable device,” according to the statement. “We’ll also continue to follow implanted patients in existing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved. We’re dedicated to developing treatments that help patients with vascular and other heart diseases live their fullest lives.”
Some studies showed that patients implanted with the BVS had a higher rate of stent thrombosis than patients implanted with Abbott’s metallic everolimus-eluting stent (Xience). Some experts attributed the difference to implanting the BVS in patients whose arteries were too small for it, and not using optimal implantation techniques.
With regard to existing products, “physicians can implant Absorb with their available inventory if they choose to do so. In [the European Union], this applies only to centers currently participating in approved clinical studies,” according to the statement.
The BVS (Absorb GT1 Bioresorbable Vascular Scaffold) was approved by the FDA for treatment of patients with CAD in July 2016.
Perspective
Back to Top
Ajay J. Kirtane, MD, SM
Without a proven benefit of the device at this time, it is difficult to justify clinical use of it. The case isn’t closed though, because if there were a benefit of the device, it would only become manifest at 3 years and beyond. That is why the late follow-up of the existing trials is important. Either way though, because the device is more difficult to use and has less tolerance for variability in implantation technique (with thrombosis observed), there will still be limited enthusiasm for this device. Future generations of BVS technology with thinner struts and other design modifications may be able to overcome these issues, but this will require study.
Click Here to Manage Email Alerts