EU awards CE mark approval to InterAtrial Shunt Device for heart failure- Corvia Medical

Corvia Medical has announced CE Mark approval of its InterAtrial Shunt Device (IASD) fr heart failure. The IASD is the world's first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF).

The results of the 64-patient CE Mark study, the REDUCE LAP-HF TRIAL, were recently published in The Lancet (Volume 387, March 26, 2016) and showed that following IASD implantation, patients had significantly fewer heart failure symptoms and were able to exercise significantly longer, resulting in a substantially better quality of life. At 6 months post-implantation, median New York Heart Association (NYHA) functional class improved from 3 to 2, mean quality of life measurement (Minnesota Living with Heart Failure (MLWHF) questionnaire) improved from 49 to 36, mean 6-minute walk distance improved from 313 meters to 345 meters and mean exercise duration improved from 7.3 min to 8.2 min. Device patency (blood flow from the left to right atria) was sustained at 6 months.

The company also announced that the first group of patients have been enrolled in the follow-on REDUCE LAP-HF I TRIAL, a prospective, multicenter, randomized controlled study to evaluate the IASD in patients at up to 20 sites in the United States and up to 8 sites outside the United States.