Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint

This article was originally published in The Pink Sheet Daily

Executive Summary

The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.

You may also be interested in...



Medtronic Recall Raises Red Flag For Drug-Coated Balloons Below The Knee

Drug-coated balloons have emerged as one of the next major product segments within interventional cardiology, particularly for the treatment of peripheral arterial disease. But a recent recall from Medtronic based on clinical trial data could temper enthusiasm for using the technology below the knee in patients with critical limb ischemia.

St. Jude Halts U.S. Renal Denervation Trial, Citing Slow Patient Enrollment

Patient-recruitment challenges have led St. Jude to halt a U.S. clinical trial of its EnligHTN renal denervation system. The company says it is working with FDA to design a new trial.

Medtronic Renal Denervation System Provides Durable Blood Pressure Benefits In Longest Trial To Date

The latest results from Medtronic’s SYMPLICITY HTN-2 trial show that patients treated for severe hypertension with the company’s Symplicity radio frequency renal denervation system showed a sustained reduction in blood pressure. The firm also announced the start of a renal denervation trial in patients with moderate hypertension.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel