Medtronic wins expanded FDA nod for SelectSure pacing leads

Medtronic (NYSE:MDT) said today it won expanded FDA labeling for its SelectSecure MRI SureScan model 3830 cardiac pacing leads, now approved for His-bundle pacing.
The Fridley, Minn.-based company said its bipolar, steroid-eluting SelectSecure leads are designed to be attached to a single or dual chamber pace maker and are now approved for pacing and sensing in the atrium, right ventricle or at the bund of HIS as an alternative to right ventricular placing.
Medtronic said it also offers a C315HIS deliver catheter for placing leads at or near the His bundle.
“There is growing interest among some physicians in His-bundle pacing as an alternative to right ventricular pacing, and we are pleased to offer the SelectSecure MRI lead for those who would like the option of this pacing approach for appropriate patients,” cardiac rhythm and heart failure division chief medical officer Dr. Rob Kowal said in a prepared statement.
Yesterday, Medtronic said it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach.
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Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news