• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Medtronic touts E.U., Aussie wins for next-gen Symplicity renal denervation components

Medtronic touts E.U., Aussie wins for next-gen Symplicity renal denervation components

December 5, 2013 By Arezu Sarvestani

Medtronic touts E.U., Aussie wins for next-gen Symplicity renal denervation accessories

Minnesota medical device maker Medtronic (NYSE:MDT) today announced regulatory wins in Australia and the European Union for next-generation components of its Symplicity renal denervation system, designed to help treat patients with chronic, drug-resistant high blood pressure.

The company won CE Mark approval in Europe and Therapeutic Goods Administration in Australia for the "highly flexible" new Symplicity Spyral catheter and Symplicity G3 RF generator, both designed to streamline renal denervation procedures.

"As we continue to drive the future of renal denervation as a treatment for uncontrolled hypertension, we are excited to deliver our fast and efficient multi-electrode Symplicity Spyral system, inspired by years of clinical experience and collaboration with top thought leaders in the field," Medtronic renal denervation vice president & general manager Nina Goodheart said in prepared remarks. "We have significantly enhanced our technology with sophisticated features designed to meet specific unmet needs and we believe these improvements, coupled with our strong safety and efficacy profile, will provide unprecedented benefit to both patients and physicians."

The Symplicity Spyral features 4 electrodes capable of delivering simultaneous or selective energy to the renal artery wall. The Spyral catheter was designed to be flexible enough to conform to the size and shape of blood vessels, capable of accommodating diameters between 3mm and 8mm, according to Medtronic.

The new G3 RF generator, which includes the safety components and treatment algorithms present in the Symplicity line, also features a new touch-screen interface that still works with the single-electrode Symplicity catheter.

Feature: Deflating the hype: Are we setting renal denervation up for disappointment?

The news marks more progress for Medtronic’s Symplicity line, for which the company recently unveiled 3-year results from Symplicity HTN-2, a randomized, controlled but un-blinded study of 106 patients in Europe, Australia and New Zealand. The device maker is also slated this coming spring to unveil highly anticipated results from Symplicity HTN-3, the 1st controlled, randomized and blinded clinical trial examining renal denervation.

The FDA granted Medtronic Investigational Device Exemption to launched SYMPLICITY HTN-4, a randomized, controlled and blinded clinical trial of up to 580 patients from around 100 clinical sites. The study will serve not only to advance Medtronic’s Symplicity system toward U.S. approval but may help generally validate renal denervation in treatment of patients with less severe hypertension.

Medtronic is a front-runner in the race to bring renal denervation technology to the U.S., although the market has lost some of its shine. The technology, once a darling of medical device conferences and industry headlines, has lost some of its charm over the last year as the market proved less lively than previously expected. Some of the reports issued during this year’s TCT meeting may help rejuvenate interest in the procedure, which researchers have suggested may have applications in ailments ranging from chronic kidney disease to diabetes and obstructive sleep apnea.

Filed Under: News Well, Regulatory/Compliance Tagged With: Ablation, Minnesota, Renal

More recent news

  • Imperative Care has positive stroke treatment study results
  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • Intuitive demonstrates remote telesurgery capabilities with da Vinci 5
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • CVRx announces Medicare win for Barostim therapy

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. 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.

Privacy Policy