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.
CardioDx is touting new study data finding that its Corus CAD diagnostic is effective in helping physicians determining whether patients have obstructive coronary artery disease before recommending costlier tests and treatments.
Researchers in Ireland and Poland are testing what could be the next big stent innovation: Coating the devices with human-derived antibodies to conceal them from the body's immune system.
During Boston Scientific's summer of $3.4 billion discontent, interim CEO Hank Kucheman told FierceMedicalDevices that the company plans to roll out new devices over the next year to turn its flagging cardiac business around. So far, he's kept his word, and now Boston Sci is launching the Emerge coronary catheter in the U.S. market.