Enpath Receives European Approval for Epicardial Steroid Lead

Enpath Medical has received CE approval from the EU to begin marketing its steroid epicardial lead in Europe for one of its two contract customers for this product.

Enpath expects sales to the European market to commence immediately. It anticipates CE approval on a second version of the steroid epicardial lead for its other contract customer in the next several weeks.

The company also reported that the FDA has indicated it will require prospective human clinical data prior to approving the company's submission of its steroid epicardial lead. Enpath said it is in discussion with the FDA regarding the amount of human clinical data required for eventual premarket approval, but that the scope and the timing of collecting the human data is yet to be determined.