Feature | January 09, 2014

Medtronic Says its U.S. Renal Denervation Pivotal Trial Fails to Meet Primary Efficacy Endpoint

Data casts doubt on the future of denervation technology

Medtronic, symplicity, renal denervation
January 9, 2014 — Medtronic Inc. announced its U.S. pivotal trial for its Symplicity renal denervation system to treat resistant hypertension, the SYMPLICITY HTN-3 trial, failed to meet its primary efficacy endpoint. The trial met its primary safety endpoint, and the trial's Data Safety Monitoring Board (DSMB) concluded that there were no safety concerns in the study.
 
This comes as a major blow to advocates for denervation therapy, which has been a hot new technology topic for interventional cardiology. Symplicity was the first renal denervation system to enter U.S. pivotal trials and was widely expected to be the first renal denervation system to be approved by the U.S. Food and Drug Administration (FDA). Several companies are now developing competing technologies renal denervation therapy technologies. However, the data from this trial now casts doubt on the Symplicity device and renal denervation therapy.
 
"SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months," said Deepak L. Bhatt, M.D., M.P.H., executive director of interventional cardiovascular programs at Brigham and Women's Hospital Heart and Vascular Center, professor of medicine at Harvard Medical School and co-principal investigator of SYMPLICITY HTN-3. "Importantly, however, the trial did not meet its primary efficacy endpoint."
 
George Bakris, M.D., professor of medicine and director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine, past-president of the American Society of Hypertension and co-principal investigator of SYMPLICITY HTN-3 stated, "While it's disappointing the trial did not meet its primary efficacy endpoint, this is the most rigorous renal denervation clinical trial conducted to date, and the first of its kind to include a sham-control group. We look forward to advancing these data into the peer review process and will submit these findings for presentation and scientific discussion at an upcoming scientific congress."
 
Patient Safety
In light of the product's demonstrated safety profile, including the SYMPLICITY HTN-3 findings, no specific action is currently indicated for patients who have had the renal denervation procedure with the Symplicity system. Patients should consult with their physician regarding any questions they may have about their treatment.
 
Future of Medtronic’s Denervation Program
Based on these clinical trial findings, Medtronic intends to formulate a panel of independent advisors made up of physicians and researchers who will be asked to make recommendations about the future of the global hypertension clinical trial program, as well as provide advice on continued physician and patient access to the Symplicity technology in countries with regulatory approvals.
 
Pending this panel review, the company intends to:
  • Suspend enrollment in the three countries where renal denervation hypertension trials are being conducted for regulatory approvals (SYMPLICITY HTN-4 in the U.S., HTN-Japan and HTN-India).
  • Begin informing clinical trial sites and investigators, global regulatory bodies, and customers of these findings and decisions.
  • Continue to ensure patient access to the Symplicity technology at the discretion of their physicians in markets where it is approved.
  • Continue the Global SYMPLICITY post-market surveillance registry and renal denervation studies evaluating other non-hypertension indications.
 
"We are disappointed that the clinical trial failed to meet its primary efficacy endpoint," said Rick Kuntz, M.D., chief medical officer of Medtronic. "We believe this course of action is the most prudent and will help us thoroughly evaluate these findings and determine the appropriate next steps for renal denervation therapy."
 
Medtronic said the company is evaluating the carrying value of the renal denervation assets and based on the above trial results, believes a one-time impairment charge in the future will be likely. The company reiterated its previously communicated revenue outlook and diluted earnings per share guidance for fiscal year 2014.
 
SYMPLICITY HTN-3 Clinical Trial?
SYMPLICITY HTN-3 is the first U.S. blinded, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the investigational Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg. Follow-up for all patients randomized in the trial will continue as planned out to five years.
 
The study randomized 535 treatment-resistant hypertension patients in 87 U.S. medical centers. People receiving the investigational treatment were compared with a sham-control group that did not receive treatment, with all patients continuing to take their blood pressure medications. Patients enrolled in the SYMPLICITY HTN-3 trial were randomly assigned to a group, with two out of three assigned to the treatment group and one out of three assigned to the sham-control group. In addition, those in the control group had the option to receive the treatment after the six-month assessment of the primary endpoint. The primary endpoints of the study are the change in office blood pressure from baseline to six months and incidence of major adverse events.
 
Symplicity Renal Denervation System?
The Symplicity renal denervation system use is similar to an angioplasty, where the physician inserts the small, flexible catheter into the femoral artery and threads it into both renal arteries in turn. Once the catheter tip is in place within the renal artery, the Symplicity generator is activated to deliver a controlled, low-power radio-frequency (RF) energy routine according to a proprietary algorithm aiming to deactivate the surrounding renal nerves. This, in turn, is intended to reduce hyper-activation of the sympathetic nervous system, which is an established contributor to chronic hypertension. The procedure does not involve a permanent implant.
 
For more information: www.medtronic.com, www.clinicaltrials.gov (Identifier: NCT01418261)
 

Related Content

FDA, CDRH, national evaluation system, medical device development
Feature | Business| May 04, 2016
The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to...
radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
statins, heart disease, HOPE-3 trial, intermediate-risk patients, hypertension, ACC.16
News | Pharmaceuticals| April 20, 2016
Lowering cholesterol with statins significantly reduced adverse cardiovascular events in people with average...
Boston Scientific, Fetch 2 aspiration catheter, Class 1 recall
News | Thrombectomy Devices| April 20, 2016
April 20, 2016 — Boston Scientific Corp. announced a U.S.
ischemic postconditioning, STEMI patients, clinical outcomes, ACC.16
News | Cath Lab| April 19, 2016
A large randomized controlled trial of ischemic postconditioning in patients who had experienced ST-segment elevation...
Overlay Init