Abbott has presented positive 30-day results from the first 101 patients enrolled in the second phase of the Absorb trial. Patients treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) and a low rate of major adverse cardiac events (MACE1 rate of 2.0%) at 30 days.
Abbott’s first phase of the Absorb trial has generated positive data of BVS technology on 30 patients out to three years. The second phase of the Absorb clinical trial (Cohort B) has enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support.
Abbott’s investigational BVS is a device made of polylactide, a biocompatible material that is used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed.
The bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time, once the vessel can remain open without the extra support. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to move, flex and pulsate similar to an untreated vessel.
Abbott’s BVS is unique due to the potential it has to restore the naturally occurring vessel functions, or vascular restoration therapy in the field of cardiology.
Abbott’s bioresorbable technology delivers everolimus, a drug that inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its vascular devices.
Patrick Serruys, professor of interventional cardiology of the Thoraxcentre at Erasmus University Hospital and principal investigator of the Absorb trial, said: “The positive 30-day results reaffirm my belief that a device that bioresorbs, or disappears, into the body after restoring blood flow is the next logical step in the treatment of cardiovascular disease.
“The continuing positive results of the Absorb trial and the clinical benefits demonstrated to date by Abbott’s bioresorbable technology show promise that a bioresorbable scaffold is on its way to becoming a clinical reality and will be the next revolution in interventional cardiology.”
Charles Simonton, divisional vice president of medical affairs and chief medical officer at Abbott Vascular, said: “The encouraging 30-day results show that Abbott’s BVS is able to restore blood flow with no cases of blood clots or repeat procedure, suggesting that there could be important clinical benefits for patients. If Abbott’s bioresorbable technology continues to perform well in clinical trials, it has the potential to become the new standard of care for patients with coronary artery disease.”