The FDA gave HeartFlow de novo clearance Monday for its FFRCT technology, the first and only noninvasive imaging technology for coronary artery disease (CAD) that shows the extent of a blockage and how it affects blood flow. HeartFlow FFRCT could potentially change the way that CAD is diagnosed and managed.
Startup Tryton Medical has raised $20 million in venture capital to submit its side branch stent to the FDA and market it in Europe. It hopes to have the first coronary stent approved to treat bifurcation lesions in the U.S. Nearly one-third of patients undergoing coronary angioplasty have bifurcation lesions, according to the company.
After a costly string of defeats with the heart drug darapladib, GlaxoSmithKline's cardio unit is rolling into Phase III with another cardiac hopeful, launching an expansive late-stage effort for losmapimod, designed to prevent repeat heart attacks.
Following news of Boston Scientific's purchase of Bayer's device unit, investors punished fellow peripheral device maker Cardiovascular Systems because it is now less likely to be bought over by the device giant.
CardioDx, the heart disease test developer that delayed plans to go public in November due to poor market conditions, has decided to test the IPO waters again. This time it will be doing it with some new leadership.
Results from a clinical trial of 59 patients with chronic ischemic heart disease and severe heart failure found that a new stem cell treatment improved heart pump function compared to the placebo group.
OrbusNeich has enrolled its first patient in a two-country proof-of-concept study for its innovative dual-therapy stent.
Germany's Biotronik has treated its first patient in a multi-center trial of its bioabsorbable vascular scaffold, a study aimed at winning a CE mark for the coronary artery disease-treating device.
Abbott Laboratories won Japanese approval for its Xience Xpedition drug-eluting stent, plotting to launch the device in one of the world's largest markets and pad sales in its flagging vascular business.
In the fiercely competitive global stent market, Abbott seems to view size as mattering most.