BEIJING – China has cleared for marketing the country's first domestically developed artificial heart, according to Chongqing, Sichuan province-based regulators. Evaheart I was developed by Chongqing Evaheart Medical Device Co. Ltd.

Croívalve, a Dublin-based startup supported by Enterprise Ireland that is developing a treatment for tricuspid regurgitation (TR), recently secured €4 million (US$4.4 million) in additional financing. The financing includes €2.5 million from the EU's Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors Halo Business Angel Network Medtech and Irrus Syndicates, Atlantic Bridge University Fund and Sos Ventures. The funding will accelerate the development of the company's technology into first-in-human (FIH) studies.

The recent progress in interventional cardiology has largely been driven by the aortic valve, although calcification of the aortic root has proven a difficult hurdle to overcome. A newly published study demonstrates that the Tendyne device by Abbott Vascular Inc., of Santa Clara, Calif., can be readily used not just to treat failing mitral valves, but works well in these patients with severe calcification, an achievement that could quickly vault the transcatheter approach past conventional surgical approaches in this population.

The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.