Abbott has announced the initiation of the next phase of the ABSORB clinical trial to evaluate the safety and performance of the company's fully bioabsorbable drug eluting coronary stent. According to a press release from Abbott, this will be the second phase of the clinical trial, enrolling about 80 patients in different international centers. The clinical trial will incorporate device enhancements the company says are designed to improve deliverability and vessel support. The first patient has been enrolled into the second stage of the ABSORB clinical trial at Onze Lieve Vrouw Ziekenhuis Hospital in Aalst, Belgium, by Bernard De Bruyne, M.D., Ph.D.

"Interventional cardiology has come a long way. It started with balloon angioplasty, which evolved into bare metal stents and then drug eluting metal stents were created," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and principal investigator of the ABSORB trial, in the Abbott press release. "Now we have the fourth revolution in interventional cardiology technology, and patient outcomes from the first stage of ABSORB clearly show that bioabsorbable devices are the future of coronary artery disease treatment."

Results from the first stage showed the ABSORB successfully treated coronary artery disease, and that at two years, the treated vessel was able to expand and contract, without being restricted by a permanent implant, which indicated that the device was absorbed. In addition, the study showed no cases of thrombosis (blood clot formation) out to two years of follow-up. There were no new major adverse cardiac events (MACE) between six months and two years. The device demonstrated a MACE rate of 3.6 percent (one patient) at two years.

"Based on the strong clinical outcomes from the first stage of Abbott's bioabsorbable device trial, interventional cardiologists have been eager to enroll their patients into the second stage of the trial," said John Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator in the ABSORB trial. "If the bioabsorbable stent continues to perform well in this trial and subsequent larger trials with more complex narrowings, bioabsorbable device technology may become the new standard of care for patients with coronary artery disease."

Abbott says it is the only company with long-term clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent. The company says its bioabsorbable everolimus eluting coronary device is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants. The stent restores blood flow by opening and supporting a vessel, but will be eventually metabolized by the body and absorbed.

Source: Abbott

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