Biotronik said today it launched its Plexa ProMRI 7.8 French MR conditional tachycardia lead in the US, touting it as the smallest lead of it’s kind on the market.
The company said it won FDA approval for the leads in February 1, indicated for use with implantable cardioverter defibrillators and heart failure devices.
“This is another advancement in efforts to further improve the performance and maneuverability of ICD leads. Patients who require ICDs are understandably concerned about reliability, and that underscores the need for durable ICD leads to choose from,” Dr. Theofanie Mela of the Massachusetts General Hospital, one of the 1st physicians in the US to implant Plexa, said in a prepared statement.
Biotronik touted that the newly launched lead’s design maximizes durability by extending to the area between the distal and proximal shock coils with negligible impact on electrical impedance.
“Biotronik is committed to continuously advancing the quality of our cardiovascular solutions for patients and physicians because excellence never rests. With a commitment to clinical 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 consistently surpasses expectations,” prez Marlou Janssen said in a press release.
In February, Biotronik said it won FDA approval for its Pro-Kinetic Energy cobalt chromium coronary stent system, with indication for use in patients with arterial blockages between 2.25 and 4mm in diameter and lesion length up to 31 mm.
The Pro-Kinetic Energy stent system is designed to imProve coronary luminal diameter in patients with new or recurring blockages in the coronary arteries. The Berlin, Germany-based company said FDA apProval of the device based off of results from its Biohelix-I clinical study.