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.
While Abbott Laboratories leads the way in the dissolvable stent market, California's Elixir Medical is right on its heels, winning CE mark approval for the DESolve device.
Cardiovascular Systems can now add a PMA submission to its aggressively confident 2013. The Minnesota company said it completed a premarket approval application with the FDA for a new device designed to treat calcified coronary arteries.
Researchers are warning that some overweight heart failure patients with CRT-D implants (cardiac resynchronization therapy with defibrillation) shouldn't necessarily shed those extra pounds. If they do, the scientists found in a massive study of nearly 1,000 patients, these folks could develop even worse heart failure or die.
CardioDx is promoting yet another post-marketing study whose data may help the company's gene expression test for obstructive coronary artery disease reach more patients, better compete with the standard of care build and also build vital market share.
TriReme Medical pulled in an $18 million financing round to propel new product development and broaden the commercial sales of its coronary and peripheral artery disease treatment devices.
Volcano is wrapping up 2012 with an acquisition. Long rumored to be an acquisition target itself, the company will buy Sync-Rx for an undisclosed price.
The FDA approved Cook Medical's Zilver PTX to treat peripheral artery disease, making the device the first drug-eluting stent indicated for PAD in the U.S.