Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

ReCor Medical has positive renal denervation study news

May 17, 2021 By Chris Newmarker

ReCor Medical Paradise renal denervation catheter system

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Medtronic, though, has since sought trial designs that clear up confounding factors such as differing medication regimens and patient compliance. (Renal denervation study results involving Medtronic are expected out of EuroPCR tomorrow.) The ReCor-funded Radiance-HTN Trio study appears to have done the same, requiring all 989 people in the study upon enrollment to switch to a 3-in-1 combo blood pressure medication to better ensure adherence.

The randomized sham-controlled found a median reduction of 8.0 mmHg in daytime ambulatory systolic blood pressure after two months among those who had undergone a procedure with ReCor Medical’s Paradise ultrasound renal denervation system. The reduction was 4.5 mmHg greater than the drop experienced among those who had undergone a sham procedure.

“Radiance-HTN Trio is the first study of its kind — a sham-controlled study where all patients were placed on a guideline-recommended regimen of three antihypertensive medications and then confirmed to have hypertension resistant to this regimen,” said co-principal investigator Dr. Ajay J. Kirtane, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons.

“These data confirm the blood pressure-lowering effect of the Paradise ultrasound renal denervation system in patients with resistant hypertension,” Kirtane said in a ReCor Medical news release.

Dr. Michel Azizi, co-principal investigator and professor of medicine at the Université de Paris, added that the study took place over a number of years at dozens of committed study centers in the U.S. and Europe.

“By lowering blood pressure in resistant hypertensive patients, endovascular ultrasound renal denervation may become a valuable tool in the treatment of hypertension in this broad class of patients in need,” Azizi said.

Palo Alto, Calif.–based ReCor Medical, which is owned by Japanese conglomerate Otsuka Holdings, paid for the study, with Kirtane also reporting institutional funding to Columbia University and the Cardiovascular Research Foundation.

The Paradise system bears has a CE mark in Europe and is an investigational device in the United States. It’s presently under investigation in the U.S. and Europe in the FDA IDE Radiance-HTN clinical study and in the ongoing FDA IDE pivotal study (Radiance-II), with enrollment completion expected this year.

Related Articles Read More >

Medtronic HeartWare HVAD
Another Medtronic HVAD recall is serious
A cylindrical-shaped medical device with a blue cap on one end and a brown cap on the other
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
FDA logo
FDA seeking innovations to move beyond heater-cooler device problems
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I

DeviceTalks Weekly.

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech