A first-of-its kind heart device that American healthcare products company Abbott Laboratories is developing has shown promising results in a new trial.
Abbott's Absorb Bioresorbable Vascular Scaffold (BVS) functions like a stent in that it opens clogged arteries to restore normal blood flow but unlike metal stents that remain in place, the medical device eventually dissolves and is absorbed by the body over time.
Absorb, which is made of polylactide, a material popularly used in medical implants because it degrades into harmless lactic acid, softens after several months and will dissolve in two or three years allowing the artery to resume more natural movements and functions, which could otherwise be restricted with a permanent metallic stent caged in the blood vessel.
In the Absorb II randomized study, investigators found that Absorb was as good as Xience, Abbot's leading drug-coated metal stent. For the trial, the results of which were presented at the 26th Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D.C. which runs from Sept. 13 to 17, researchers involved 501 individuals with coronary artery disease who either received Absorb or Xience.
After one year, the researchers found that the patients who received Absorb had lesser incidence of angina, which is characterized by severe pain in the chest that could spread to the arms, neck and shoulders and is caused by diminished blood supply to the heart. The condition requires repeat visits to the doctor and can hamper the activities of the patient. Of the patients who received Absorb, the rate of angina was 16.4 percent while the incidence was 25.6 percent in patients who received Xience.
"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. "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 trial also revealed that heart attacks, repeat procedures and deaths occurred in 9.1 percent of patients treated with Xience but the rate is reduced to only 7.3 percent in patients who received Absorb.
"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 Abbott Vascular chief medical officer Charles Simonton.