World’s First Drug Eluting Bioresorbable Stent Gains CE Mark Approval

January 10th, 2011

World’s First Drug Eluting Bioresorbable Stent Gains CE Mark Approval

Larry Husten, PHD

Abbott announced today that it had received CE Mark approval for Absorb, its bioresorbable vascular scaffold (BVS) device. The device props a narrowed coronary artery open but then dissolves within 2 years, leaving the patient without a permanent implant. One hope for the device is that it will allow stent patients to safely discontinue dual antiplatelet therapy at an earlier time.

“Abbott’s Absorb has the potential to change the way patients with coronary artery disease are treated, as it does what no other drug eluting coronary device has been able to do before – completely dissolve and potentially restore natural vessel function in a way not possible with permanent metallic implants,” said Patrick Serruys, in an Abbott press release.

Abbott said that the new device will be available “in select sizes to a limited number of centers in Europe later this year and into 2012.” A full commercial launch in Europe will not take place until late 2012. Abbott also announced plans for a 500-patient European study comparing Absorb to Abbott’s Xience Prime. A global trial is also planned for later in the year.

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January 10th, 2011