Medtronic (NYSE:MDT) today said it’s taking another crack at renal denervation as a treatment for hypertension with the launch of a clinical program to examine the "confounding factors" that contributed to the high-profile failure of a prior trial.
Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity-3 trial failed to meet its efficacy endpoint. The company suspend enrollment in its other Symplicity trials around the world and later took a $200 million writedown on its renal denervation assets.
News of the trials failure reverberated throughout the medical device industry, prompting other companies to follow suit by either scaling back their RDN programs or spiking them altogether.
Today Medtronic said it won an investigational device exemption from the FDA for its global Spyral HTN program, beginning with a pair of studies using the next generation of its Symplicity line, the Symplicity Spyral catheter and Symplicity G3 radiofrequency generator. CFO Gary Ellis said in February that the company planned to submit for IDE approval from the FDA, but declined to go into detail on Medtronic’s new RDN program.
The 2 new trials, Spyral HTN-Off Med and Spyral HTN-On Med, are designed to examine RDN with and without high blood pressure medication. Unlike the Symplicity-3 trial and its cohort of severe, treatment-resistant high blood pressure, each 100-patient trial is slated to enroll subjects with moderate- to high-risk hypertension, Medtronic said.
Spyral Off-Med aims to isolate the effect of RDN on high blood pressure. Spyral On-Med is designed to evaluate the treatment with the use of anti-hypertensive medications, but not at the maximum doses required by Symplicity-3’s protocol. Patient compliance with the medication regimen will also be closely monitored and patients will be tracked using ambulatory blood pressure measurements, according to the company.
Depending on the studies’ outcomes, Medtronic said it will consider a pivotal trial ahead of bids for pre-market approval in the U.S. and Shonin approval in Japan.
"Medtronic believes the underlying science behind renal denervation is strong and that there is a clear, unmet need for people with uncontrolled hypertension. Therefore, we remain committed to exploring the clinical potential of renal denervation in this population," coronary & renal denervation general manager Jason Weidman said in prepared remarks. "To get to this point, we’ve performed extensive analyses and conducted additional pre-clinical testing following the Symplicity HTN-3 trial. We’ve also consulted with the FDA and reimbursement bodies, and partnered with renowned thought-leaders worldwide to develop this novel clinical trial protocol."
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