A blog about what is new (and old) in the world of active implantable medical devices

Monthly Archives: August 2019

FDA Approves Boston Scientific’s ImageReady™ MRI For Vercise Gevia™ DBS

Posted on by Posted in Boston Scientific, Brain Stimulation, MRI-safe, Parkinson's Disease

 

Image Credit: Boston Scientific

Boston Scientific announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™  Deep Brain Stimulation (DBS) System to be used in a full-body MRI (1.5 Tesla MRI conditional when all conditions of use are met).  This system, with the Vercise Cartesia™ Directional Lead, is designed to treat the symptoms of Parkinson’s Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.

 

Medtronic Q1 FY2020: Cardiac Rhythm & Heart Failure Down 3.1%, Pain Therapies Down 7%

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Medtronic, Neural Stimulation, Pain, Spinal Cord Stimulation, Tachycardia, Uncategorized

Medtronic announced today its financial results for its first quarter of fiscal year 2020.  As a whole, the company reported first quarter worldwide revenue of $7.493 billion, an increase of 1.5 percent.

However, Cardiac Rhythm & Heart Failure decreased 3.1 percent as reported (1.2 percent on a constant currency basis).   According to the press release”

“Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth in Pacemakers, including mid-twenties growth of the Micra® transcatheter pacing system, as well as mid-thirties growth of the TYRX® absorbable antibacterial envelope, high-single digit growth of the Reveal LINQTM insertable cardiac monitoring system, and high-single digit growth in AF Solutions, all on a constant currency basis. Arrhythmia Management growth was offset by low-double digit declines in Heart Failure, including high-forties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.”

Pain Therapies, the other area of Medtronic’s business that depends heavily on active implantable medical devices also took a hit, with first quarter revenue of $292 million decreased 7.0 percent as reported or 6.1 percent on a constant currency basis.   The announcement explains:

“Pain Stimulation declined in the low-double digits, reflecting channel destocking and the overall slowdown of the spinal cord stimulation market.”

 

CVRx Receives FDA Approval for its BAROSTIM NEO™ to Treat Heart Failure

Posted on by Posted in Baroreceptor Stimulation, CVRx, Heart Failure (CHF)

Image Credit: CVRx

 

 

Minneapolis-based CVRx received FDA approval yesterday for its BAROSTIM NEO™ device to treat Heart Failure.

The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors.  The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

The no-panel approval was based on results from CVRx’s BeAT-HF phase III trial on 264 patients randomized to two arms: 130 subjects randomized to receive a BAROSTIM NEO™ were compared to 134 subjects randomized to stay on guideline-directed medical therapy.   The implanted group showed the following improvement in symptomatic endpoints as compared to the control group:

  • Improved their MLWHFQ score by 14 points,
  • Improved their 6-minute hall walk by 60 meters, and
  • Improved their NYHA status.

According to FDA’s press release, the BAROSTIM NEO™ System is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.

CVRx website:  www.cvrx.com