MedicalCV Inc. To Amend 510(k) Submission Of Its Automated Surgical Ablation System For Cardiac Tissue Ablation To Seek Soft Tissue Clearance

INVER GROVE HEIGHTS, Minn.--(BUSINESS WIRE)--MedicalCV, Inc. (OTCBB:MCVI), a cardiovascular surgery company, announced today that it has determined to amend its 510(k) submission for clearance of its SOLAR™ automated surgical ablation system. The Company will initially seek a soft tissue clearance. The SOLAR System, the latest innovative 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 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.
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