LAKE OSWEGO, Ore., April 18, 2017 /PRNewswire/ -- After nearly a decade of research and development, BIOTRONIK today announced the launch of Plexa ProMRI®, the smallest (7.8F) MR conditional tachycardia lead available in the United States. The US Food and Drug Administration (FDA) approved Plexa ProMRI on February 1, 2017 for use with implantable cardioverter defibrillators (ICDs) and heart failure devices.
The lead's performance-driven, high-voltage wire design maximizes durability by extending to the area between the distal and proximal shock coil, with negligible impact on electrical impedance. The lead's design offers physicians uniform handling during placement and the modified screw performs more reliably in their hands.
"This is another advancement in efforts to further improve the performance and maneuverability of ICD leads," said Dr. Theofanie Mela, an electrophysiologist at Massachusetts General Hospital and one of the first physicians in the US to implant Plexa. "Patients who require ICDs are understandably concerned about reliability, and that underscores the need for durable ICD leads to choose from."
Plexa ProMRI's suite of tactile design elements provides physicians with an advanced, high-performing, MR conditional ICD lead for tachycardia patients with various patient anatomies. Plexa ProMRI leads are available in various DF4, DF-1 and DX configurations.
"BIOTRONIK is committed to continuously advancing the quality of our cardiovascular solutions for patients and physicians because excellence never rests," said Marlou Janssen, President, BIOTRONIK, Inc. "With a commitment to clinicial research, we have championed reliable leads for more than 50 years. BIOTRONIK invested nearly a decade of research and development to bring Plexa ProMRI to market and we'll continue these efforts to ensure Plexa ProMRI consistenly surpasses expectations."
BIOTRONIK enrolls more patients in US lead studies than any other global cardiac rhythm management device company, and invests in ongoing large-scale prospective studies that assess real-world lead performance to provide hospitals, physicians and patients with proven and reliable cardiovascular solutions.
A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris*, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar**, the world's first 4 F compatible stent for treating long lesions; Orsiro**, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.
* Not currently available in the United States.
** CAUTION – Investigational device. Limited by United States law to investigational use.
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