medical device guru

Pacemaker-Like Implant Cleared in Europe to Lower Blood Pressure

Cardiovascular / Cardiology September 5, 2019

Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions.

Additionally, the Cardiovascular Research Foundation (CRF) selected Orchestra BioMed’s MODERATO II clinical study of BackBeat CNT for a late-breaking science presentation at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 annual conference on September 28, 2019 at 12:45 pm PST in the main arena at The Moscone Center in San Francisco. The presentation titled, “MODERATO II: A Double-Blind Randomized Trial of Cardiac Neuromodulation Therapy in Patients with Hypertension,” will be presented by Karl-Heinz Kuck, MD., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO Studies. The MODERATO II results will also be highlighted at a press conference to be held at TCT during the morning of September 28, 2019. Every year, TCT late-breaking presentations feature major medical research breakthroughs and highlight the latest data on the most innovative treatments that will impact patient care and how physicians treat heart disease. The studies selected examine the safety and efficacy of minimally invasive techniques, pharmaceuticals, therapies and devices that demonstrate potential to treat or prevent cardiovascular disease.

“BackBeat CNT is an exciting new approach to device-based blood pressure management and has potential to be a primary treatment modality for the more than two-thirds of pacemaker patients at risk from hypertension,” said Dr. Karl-Heinz Kuck. “In the MODERATO I clinical trial, BackBeat CNT demonstrated excellent efficacy and safety results, particularly given that 78% of the study patients had isolated systolic hypertension and that patients’ average baseline ambulatory systolic blood pressure (137 mmHg) was lower compared to patients in other device-based hypertension studies. I look forward to presenting the six-month primary endpoint results from the MODERATO II study of BackBeat CNT as a late-breaker at TCT later this month.”

“CE Mark approval and selection for late-breaking science presentation at TCT validate the potential for BackBeat CNT to benefit targeted high-risk hypertensive patients, such as those already indicated for a pacemaker,” said David Hochman, Chairman and CEO of Orchestra BioMed. “Effective treatment of these patients, the majority of whom have isolated systolic disease and persistent high blood pressure despite conventional pharmaceutical therapies, represents a significant market opportunity that could have substantial growth, value and market share implications for the field of cardiac rhythm management.”

See Full Press Release: Orchestra BioMed Receives CE Mark for BackBeat Cardiac Neuromodulation Therapy™ (CNT) for Hypertension


Press Release by: Orchestra BioMed™, Inc.


A Specialty Recruiting Firm Exclusively Servicing The Medical Device Industry

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?

Contact us to discuss partnering with Legacy MedSearch on your position.

AUTHOR - Authorship Credit Noted Above
SHARE
YOUR FIRST STEP TO SUCCESS
IS JUST A CLICK AWAY
Search our current open opportunities to take your first step to success in Medical Device and Healthcare IT today. Focusing on you and your career is our Job, now it’s time for you to find yours. Let’s get started.
VIEW JOBS