July 29, 2019
Alvimedica Receives European Approval for 1-Month DAPT After Implantation of Cre8 and Cre8 Evo DES
July 30, 2019—Alvimedica announced European regulatory approval for 1-month duration of dual antiplatelet therapy (DAPT), when clinically indicated, after implantation of the company's Cre8 and the Cre8 Evo drug-eluting stents (DESs).
According to the company, the approval, which applies to devices distributed in all countries that recognize CE Mark, allows physicians to provide more extensive treatment coverage for those patients with coronary artery disease who are at high risk of bleeding and, as a consequence, need particular care. The company reported that 1-year clinical data indicate low stent thrombosis rates and no observed increased risk for stent thrombosis when unanticipated interruption or discontinuation of DAPT is required any time after 1 month of implantation of Cre8 devices.
Guidelines for patients who receive DESs generally recommend daily compliance of DAPT for up to 6 or 12 months, but some patients interrupt or discontinue their regimen early for a variety of reasons, and these patients are often the most complex. The technologies embedded in the Cre8 product family minimize the possible severe adverse events that may be experienced by patients who interrupt or discontinue their DAPT regimen, stated the company.
Alvimedica advised that physicians should adhere to DAPT duration defined in the current guidelines for percutaneous coronary interventions issued by the European Society of Cardiology or those of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions, but the decision to interrupt or discontinue DAPT is the responsibility of the treating physician, taking into consideration the individual patient’s condition.