Category: Cardiac Implants
Medical device giant St. Jude Medical wins CE Mark approval in the European Union for 2 defibrillator product portfolios designed to reduce lead abrasion, the most common type of lead insulation failure.
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.
Biotronik wins FDA approval for its next-generation Ilesto 7 suite of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.
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.
St. Jude Medical enrolls the 1st patient in a clinical trial of its next-generation Quadra Assura MP multi-point cardiac pacing system in patients with heart failure.
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.
Personal injury lawsuits filed against St. Jude Medical allege that its Riata defibrillator leads were defective and caused injuries or deaths of more than 30 patients.
The FDA's Circulatory System Devices Panel was divided this week on recommending approval for Abbott Vascular's first-of-a kind MitraClip heart implant for the reduction of mitral valve regurgitation.
An FDA advisory panel yesterday narrowly recommended approval for the first-of-a-kind MitraClip heart implant made by Abbott (NYSE:ABT), designed to prevent blood from flowing backward across the mitral valve.
Syncardia reels in $19 million for its total artificial heart, hard on the heels of a nod from the FDA for the device.
Syncardia put together a $19 million financing package to back the spinout of its total artificial heart technology, hard on the heels of an FDA win for the device.
The bulk of the financing, $15 million, was doled out by New York-based funding group Athyrium Investors, with the balance coming from existing backers.
Massachusetts-based DC Devices closes a $10.7 million equity funding round with 10 investors backing its catheter-based InterAtrial Shunt Device for treatment of diastolic heart failure.
Massachusetts-based medical device startup DC Devices closed a $10.7 million funding round in support of its minimally invasive treatment for heart failure.
DC Devices "seeks to become the leading medical device company for the treatment of congestive heart failure," according to its page on the website of venture capital firm General Catalyst.