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

Category Archives: BackBeat Medical

Orchestra Biomedical Receives Approval to Start BACKBEAT IDE

Posted on by Posted in BackBeat Medical, Bradycardia, Cardiac Pacing, Hypertension, Medtronic, Orchestra Biomedical
Orchestra Biomed Backbeat therapy for hypertension in patients indicated for dual-chamber pacing

Image Credit: Orchestra BioMed

Orchestra Biomedical announced that it has received FDA’s approval (Sep 19, 2023) to initiate its BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) IDE study for evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™) for treating hypertensive patients who are indicated for a dual-chamber cardiac pacemaker.

Orchestra and Medtronic formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population.

BackBeat Medical Gains CE-Mark for Moderato Device for Treating Hypertension

Posted on by Posted in BackBeat Medical, Cardiac Pacing, Cardiac Stimulation (other), Hypertension

 

BackBeat® Medical in New Hope, PA, a subsidiary of Orchestra BioMed, Inc. announced that it received the CE Mark for its Moderato® device.   BackBeat’s Cardiac Neuromodulation Therapy (CNT) is a patented implantable cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure. The stimulation algorithms in the Moderato® device are designed such that they simultaneously modulate autonomic nervous system responses that normally drive and maintain blood pressure higher. The Moderato® device also provides standard DDDR pacemaker functions.

The Cardiovascular Research Foundation (CRF) selected the MODERATO II clinical study for a late-breaking science presentation at TCT 2019 (September 28, 2019) by Karl-Heinz Kuck, MD., Ph.D., Director of Cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO Studies.

The website for BackBeat is at: https://orchestrabiomed.com/technology/backbeat-cnt/

 

BackBeat® Medical’s Cardiac Neuromodulation Therapy (CNT) for Hypertension

Posted on by Posted in BackBeat Medical, Cardiac Neuromodulation, Hypertension

Image Credit: BackBeat Medical

BackBeat® Medical in New Hope, PA is a subsidiary of Orchestra BioMed, Inc.   BackBeat’s Cardiac Neuromodulation Therapy (CNT) is a patented implantable cardiac stimulation-based treatment for hypertension that the company claims immediately and substantially lowers blood pressure. The stimulation algorithms are designed such that they simultaneously modulate autonomic nervous system responses that normally drive and maintain blood pressure higher.  This is explained in the following video:

According to a paper presented at AHA in 2017:

“The Moderato System (BackBeat Medical, New Hope, PA), is a dual-chamber, rate-responsive pacemaker implantable pulse generator (IPG), which incorporates PHC algorithms that pace the heart with a series of variably timed, alternating shorter (eg, 20–80 ms) and longer (eg, 100–180 ms) atrioventricular intervals. Details of PHC therapy optimization are discussed below; in general, the pacing sequence consists of 8 to 13 beats with the shorter atrioventricular delay followed by 1 to 3 beats with the longer atrioventricular delay. The device is active 24 h/d and paces the right ventricle on nearly every beat.”

BackBeat presented results from its Moderato trial at TCT 2018. Clinical results with 2-year follow-up from the European MODERATO I clinical trial showed that BackBeat® CNT can reduce systolic blood pressure measured in office by an average of 23.4 mmHg, an amount that has the potential to reduce risk of heart attack and stroke by at least 50%.

According to BackBeat, the technology can be readily incorporated into existing cardiac rhythm management devices such as pacemakers using standard implant and lead placement techniques. BackBeat has indicated that it is pursuing the CE Mark for its Moderato IPG.

The website for BackBeat is at: https://orchestrabiomed.com/technology/backbeat-cnt/