A startup that's aiming to make the diagnosis of obstructive coronary artery disease part of a physician office visit has raised $5 million as it heads into a European launch of its CADence device. The company, Aum Cardiovascular--named after a Sanskrit syllable that means "to make a continuous low humming sound"--gained a CE mark for the device earlier this year.
Abbott just announced the CE marking of its latest Absorb bioresorbable stent at the annual EuroPCR conference in Paris. The device is called the Absorb GT1, in reference to its GlideTrak delivery catheter, which is supposed to make it easier for doctors to access and treat diseased vessels among coronary artery disease patients.
The catheter-based insertion of one of the latest generation of drug-coated stents is just as effective as bypass surgery in treating coronary artery disease, according to a study in the latest issue of the New England Journal of Medicine. That was not the case with the prior generations of bare metal or first-generation drug-eluting stents.
HeartFlow has raised about $36 million of a targeted $46 million private financing. The startup leapt to this sizable amount on the back of a recent FDA clearance for its FFRCT software, which is the first and only noninvasive imaging technology for coronary artery disease that shows the extent of a blockage and how it affects blood flow, according to the company.
This spring, CardioDx had readied itself again to make a run at an IPO. But it's opted to take another round of private investment instead. It has raised $35 million in equity from new investor Alberta Investment Management alongside existing investors.
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.
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.
OrbusNeich has enrolled its first patient in a two-country proof-of-concept study for its innovative dual-therapy stent.