Jan. 5, 2007 — MedicalCV, Inc., a cardiovascular surgery company, says it will amend its 510(k) submission for clearance of its SOLAR automated surgical ablation system for soft tissue ablation only following discussions with FDA and the company’s own counsel. Once clearance is obtained — which is expected imminently — Medical CV plan to market the system immediately.
The automated SOLAR System will complement the company's existing and already cleared cardiac tissue ablation platform, the ATRILAZE System, which is currently used in both open-heart and minimally invasive cardiac surgery procedures. The SOLAR System, the latest addition to the company's family of laser-based systems, is intended to enable precise delivery and consistent dosing of laser energy for ablating tissue by leveraging flexible, fiber-optic technology.
The company also indicates that following launch of the SOLAR System it will initiate design and implementation of a protocol to collect clinical data to support a subsequent regulatory submission to obtain a specific clearance of the SOLAR System for cardiac tissue ablation. MedicalCV anticipates the development of a clinical protocol for an IDE study of the SOLAR System for the specific treatment of atrial fibrillation (AF). No medical device on the market currently has FDA labeling for the treatment of AF.
