A Medical Device Daily
Cardiovascular surgery company MedicalCV (Inver Grove Heights, Minnesota) said it is determined to amend its 510(k) submission for clearance of its Solar automated surgical ablation system. The company said it will initially seek a soft tissue clearance.
The Solar System, an 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 using flexible, fiber-optic technology. Solar will complement the company's already cleared cardiac tissue ablation platform, the Atrilaze System, used in both open-heart and minimally invasive cardiac surgery procedures.
After discussions with the FDA and the company's FDA counsel, the company said it determined to amend its application to seek the soft tissue application and that it will immediately begin marketing for that use following clearance, which it said is "expected to be forthcoming."
With the launch of the Solar System, MedicalCV said it will work with its Scientific Advisory Board to design and implement 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.
The company also anticipates the development of a clinical protocol for an investigational device exemption study of Solar for the specific treatment of atrial fibrillation (AF).