The FDA said it will announce the date and the complete agenda four to six weeks before the meeting in accordance with their normal communications regarding public panel meetings.
Medtronic's PMA submission includes safety and efficacy data on more than 4,100 patients who have been treated with Endeavor in clinical trials that include follow-up for as long as four years.
The company said the Endeavor PMA sets a new standard for clinical data submitted to the FDA, with data from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new DES..
"Endeavor represents a new generation of drug-eluting stents, with a polymer-drug combination specifically designed to reduce restenosis while maintaining a favorable safety profile," said Scott Ward, president of the CardioVascular business at Medtronic.
"We have submitted a PMA that strongly supports the safety and efficacy criteria needed for approval in the United States, and we continue to anticipate approval later this calendar year."
Patient follow-up in the Endeavor clinical trials has been extensive. The number of patients included in the Endeavor PMA is nearly double the number of the two commercially available DES — Boston Scientific's (Natick, Massachusetts) Taxus and Johnson & Johnson's (New Brunswick, New Jersey) Cypher — combined at the time of their submission, the company said.