Harpoon Medical Reports on Enrollment and Funding for Early Feasibility Study of Its TMVR Device

September 21, 2015—Harpoon Medical announced that its early feasibility study of the Harpoon transcatheter mitral valve repair (TMVR) device has enrolled 10 patients with severe degenerative mitral regurgitation (MR) at two clinical study sites in Europe.

Data include a 100% procedural success rate, more than 850 total implant days, and echocardiographic data on the first two patients with trace MR at 6-month follow-up. The company will present findings from the study on October 12 at TCT 2015, the Transcatheter Cardiovascular Therapeutics scientific symposium being held October 11–15 in San Francisco, California.

The Harpoon transapical chordal echo-guided repair device is approved for investigational use in Poland where the TRACER safety and feasibility study is being conducted in up to 20 patients with degenerative MR at the Jagiellonian University in Krakow, Poland, and the Institute of Cardiology in Warsaw, Poland.

Harpoon Medical also announced that it has completed a $2 million bridge financing, which included investments for $1.4 million of convertible debt. The funds will be used to support the ongoing early feasibility study and start a larger clinical trial, which is scheduled to begin enrolling patients before the end of the year to support European CE Mark approval. 

The Harpoon device is not available for commercial use in the United States, advised the company.