With a green-light from the FDA, Elixir Medical Corporation will move forward with its Excella III pivotal trial to review its DESyne Nx Novolimus-eluting coronary stent system. Elixir plans to enroll patients at 50 clinical locations and will use the trial results to support its upcoming premarket approval application.
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
St. Jude’s new CE Marked defibrillators aim to reduce insulation abrasion
St. Jude Medical (NYSE:STJ) won European regulatory approval for 2 next-generation defibrillators, the Ellipse and the SJM Assura high voltage systems. The new devices aim to bolster device reliability by preventing lead-to-can abrasion, according to the company.
Chris Christie, Dick Cheney and the power of celebrity endorsements for medical devices
When the New York Post broke the story this week that New Jersey governor and presidential hopeful Chris Christie had underwent weight loss surgery using the LAP-BAND in February some on Wall Street bemoaned the rotund politicians timing.
Medtronic asks Supreme Court to overturn $74M loss against Edwards Lifesciences
OrbusNeich blocks German imports of Boston Scientific’s stents
OrbusNeich Medical wasted no time in enforcing a patent win against Boston Scientific (NYSE:BSX), announcing that it is blocking German imports of its rival’s cardiac stents.
FDA approves Biotronik’s “smaller, thinner” heart rhythm implants
German medical device maker Biotronik today touted FDA approval for its Ilesto 7 line of next-generation implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.
The devices are smaller, thinner and lighter and the new Ilesto DX allows physicians to monitor atrial information and possibly diagnose previously undetected instance of atrial fibrillation.
Over-stenting trial settles ahead of cardiologist Midei’s testimony
The civil lawsuit filed by former patients against cardiologist Dr. Mark Midei and his former employer over alleged over-stenting settled on the eve of Midei’s testimony, reportedly without his agreement.
The lawsuit was filed against Midei and Catholic Health Initiatives, owner of the St. Joseph Medical Center where Midei practiced, by the more than 200 patients he’s accused of implanting with unnecessary stents.
St. Jude Medical launches new study of next-gen multi-point cardiac pacing
St. Jude Medical (NYSE:STJ) enrolled the 1st patient in a clinical study evaluating pacing in multiple points on the heart, the company announced today.
Edwards Lifesciences wants more from Medtronic over CoreValve infringement
Update: Cook Medical recalls Zilver PTX delivery system following patient death
Updated April 25, 2013 with additional comments from Cook Medical.
Cook Medical recalled all sizes, diameters and lot numbers of its Zilver PTX drug-eluting stents after receiving reports of 1 death and 1 patient injury possibly associated with a breakage in the catheter delivery system. It’s not clear when the devices will be back on the market, according to a company spokesman.