Abbott has announced positive results from 101 patients enrolled in the second phase of the Absorb trial evaluating the world's first drug-eluting bioresorbable vascular scaffold for the treatment of coronary artery disease. At one year, the Absorb device demonstrated a 6.9 percent rate of major adverse cardiac events and no reports of blood clots, according to an Abbott statement. The results were presented during the American College of Cardiology's 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.
The Absorb trial enrolled 131 patients. Key endpoints include assessments of safety--major adverse cardiac events and treated-site thrombosis rates--at 30 days and at six, nine, 12 and 24 months, with additional annual clinical follow-up for up to five years. Absorb is made of polylactide, a biocompatible material commonly used in medical implants. The device is designed to slowly metabolize and eventually be resorbed by the body after providing support to the vessel during the healing process. It received the CE Mark in Europe earlier this year, but the company doesn't expect to file an application seeking U.S. regulatory approval until 2015, the Wall Street Journal notes.
As the WSJ reports, Abbott must still convince doctors to consider a dissolvable alternative to permanent stents. But Nick Ruggiero, a cardiologist with the Jefferson Heart Institute in Philadelphia, thinks it's a pretty smart idea. And study leader Dr. Patrick Serruys, a cardiologist from Erasmus University Hospital in Rotterdam, said Absorb and stents like it will ultimately improve outcomes for patients, including infants. "The baby will grow and the biodegradable material will disappear," he said, as quoted by Reuters. "That would be one compassionate use of it, a very serious application. Otherwise, you'd be forced to reopen the baby to remove metallic stents."
However, not everyone seems convinced. Renu Virmani, president and medical director at the CVPath Institute in Maryland, says doctors will have to work harder to pick the right device size and implant it with Absorb compared with metal stents, according to the WSJ. Furthermore, the company expects to charge more for the Absorb device than the permanent, medicated stents, which cost roughly $1,500 to $2,000.
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