dimarts, 29 de març del 2016

St. Jude wins CE Mark for expanded suite of cardiac leads

St. Jude MedicalSt. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched 3 new Quartet left ventricular leads.

The newly released leads are designed for more effective targeting of individual cardiac anatomies for patients who require cardiac resynchronization therapy pacers and defibs, the company said.

“Heart and blood vessel anatomy vary from patient to patient so having multiple sizes and spacing options with the Quartet quadripolar lead helps me to treat all of my patients in need of cardiac resynchronization therapy. We are now able to place the quadripolar lead in the best possible location for that patient, capturing more cardiac tissue to give heart failure patients the best opportunity to respond,” Dr. Sami Pakarinen of Finland’s Helsinki University Central Hospital said in a press release.

St. Paul, Minn.-based St. Jude Medical said the leads are designed to be used with next-gen MultiPoint Pacing technologies which allows for pacing in multiple locations on the left side of the heart.

A select number of the newly cleared products area also compatible with magnetic resonance imaging, as well as the company’s Quadra Assura CRT-D and Quadra Assura MP CRT-D with MultiPoint Pacing, the company said.

“These lead choices allow physicians to identify what lead spacing option will work best for each patient so they can individualize care. The expanded selection of quadripolar pacing leads reinforces St. Jude Medical’s leadership in quadripolar pacing and heart failure treatment options,” medical affaris veep Dr. Philip Adamson said in prepared remarks.

In February, St. Jude said the FDA approved its MultiPoint pacing technology for its Quadra Allure defibrillators and pacemakers, plus a new set of quadripolar pacing leads called Quartet LV.

The company said the MultiPoint tech is the 1st to hit the U.S. market that allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said.

The new Quartet LV leads have more electrode spacing options and a new, S-curved design, the company said.

The post St. Jude wins CE Mark for expanded suite of cardiac leads appeared first on MassDevice.



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