I’ll be presenting the keynote “AIMD-based Therapies of Heart Failure” at the First Workshop on Active Implantable Medical Devices dedicated to understanding the trends and challenges in bioelectronic medicine.
For the complete announcement of the workshop with some great talks by Rikky Muller (UC Berkeley), Pedro Arzuaga (Impulse Dynamics), Marcelo Barú (Biotronik), Federico De Mula (Integer), and Victor Pikov (Medipace) click here: AIMD Workshop LASCAS 2024 Program.
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 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/
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/
BioControl Medical, Ltd. was founded in 1999 by Yossi Gross, and is based in Yehud, Israel. BioControl’s first devices were developed to treat incontinence due to overactive bladder, stress, and interstitial cystitis. In 2006 American Medical Sytems acquired an exclusive license for the use of the technology in urology, gynecology and other pelvic health applications. Continue reading
From Patent Application Publication: US 2011/0137370 A1
Enopace Biomedical Ltd. was founded in 2008 by Yossi Gross in Caesarea, Israel.
Very scant details are available besides that it is developing a neuromodulation system to treat patients with congestive heart failure. According to the company, its technology consists of a minimally invasive, implantable neurostimulation device that increases cardiac efficiency by reducing left ventricular workload.
From Enopace’s patent applications, it seems that Enopace’s device consists of a stimulation unit that is placed within the aorta close to the heart, and which is driven wirelessly from a coil that is placed within a vein closeby to the artery. The transmitting coil is in turn driven from an implanted control unit that is implanted subcutaneously. Continue reading
Image Credit: CVRx
CVRx was founded in Minneapolis, MN in 2001 by Dr. Robert Kieval to develop an implantable system for the treatment of hypertension.
CVRx’s implantable pulse generators deliver stimulation to the baroeceptors in the carotid arteries to induce a baroreflex that causes a drop in blood pressure in patients with refractory hypertension. Continue reading
Yossi Gross (born February 5, 1947) is an Israeli medical device innovator and entrepreneur. His medical-device companies are incubated through Rainbow Medical.
Currently, the following companies led by Yossi Gross are focusing on active implantable medical devices: