Tag:

coronary artery disease

Latest Headlines

Latest Headlines

HeartFlow's noninvasive test for coronary artery disease cleared by FDA

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.

Stent developer Tryton gets $20M to complete FDA submission, market in EU

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.

GlaxoSmithKline tees up another huge cardio PhIII after darapladib flop

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.

Boston Scientific buyout threatens Cardiovascular Systems

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 revives IPO plans with infusion of fresh leadership

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.

Danish trial results show stem cells improve failing hearts

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 starts up a U.S.-Japan trial of its dual-therapy stent

OrbusNeich has enrolled its first patient in a two-country proof-of-concept study for its innovative dual-therapy stent.

Biotronik kicks off absorbable stent trial as market crowds

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 rides next-gen Xience stent into Japan

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.

Abbott CE mark covers extra-long stent size

In the fiercely competitive global stent market, Abbott seems to view size as mattering most.