Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial.
Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the around the renal arteries in treating hypertension, failed to meet its efficacy endpoint. The company suspended enrollment in its other Symplicity trials around the world and later took a $200 million write-down 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 the company said positive results from another study, the 353-patient Spyral HTN-Off Med investigational device exemption trial, prompted it to proceed with its plans to win regulatory approvals for its Symplicity Spyral ablation catheter in the U.S., Japan and elsewhere.
The Spyral HTN-Off Med study is one of a pair 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 was slated to enroll subjects with moderate- to high-risk hypertension. 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.
Data from the first 80 patients treated in Spyral Off-Med, designed to isolate the effect of RDN on high blood pressure, showed that patients in the treatment arm had a significant reduction in blood pressure compared with subjects in the sham arm at three months, Medtronic said.
Office-based systolic blood pressure measurements declined an average of 10mm HG for the treatment arm and were 7.7mm Hg lower than the sham arm, according to the study’s initial results, presented at the annual meeting of the European Society of Cardiology in Barcelona and published in The Lancet. Diastolic blood pressure in the treatment arm declined an average of 5.3mm Hg and was 4.9mm Hg lower than the sham arm.
The 7.7mm systolic difference was associated with a roughly 20% reduction in the risk for major cardiovascular events including heart attack and stroke, according to a Lancet meta-analysis.
Medtronic said there were no reported cases of new or worsening renal failure, vascular complications, or other major adverse events.
“These data confirm our long-held belief that the underlying science behind renal denervation is strong and we are committed to continuing our mission to realize the full potential of this procedure to help address an unmet need for the more than one billion people worldwide living with high blood pressure,” coronary & structural heart president Sean Salmon said in prepared remarks. “We intend to continue consulting with our physician advisors and global regulatory authorities about these results so that we can appropriately move forward with a pivotal trial design to ultimately support regulatory approval in the U.S., Japan and other countries where the technology is not currently available.”
“Based on the clinical results presented at ESC, we are confident that the Spyral HTN-Off Med Study has successfully demonstrated the treatment effect of RDN,” added co-principal investigator Dr. Michael Böhm of the University of Saarland, Germany. “With consistent and significant drops across ambulatory and office-based blood pressure-including both systolic and diastolic measurements-we are confident to be moving forward with a pivotal trial so that doctors and patients may have an alternative approach to lowering blood pressure.”
“After Symplicity HTN-3, we learned a lot about the procedure itself, medication adherence and which patients may have less response to the RDN procedure-these insights have been incorporated into the revised clinical approach in the Spyral HTN program,” co-principal investigator Dr. David Kandzari, of Atlanta’s Piedmont Heart Institute, said in the prepared release. “With this new approach and protocol design, coupled with new technology that allows more consistent circumferential treatment and easier access into the distal anatomy, based on these compelling results we are confident that we’ve appropriately addressed the issues in previous renal denervation trials.”
“These results are extremely encouraging for the more than 50 percent of hypertension patients who become non-adherent to their medications within one year of initiating therapy,” noted co-principal investigator Dr. Raymond Townsend of the University of Pennsylvania. “The societal implications are potentially huge as well, as high blood pressure contributes more than 500 billion dollars in direct costs to our healthcare systems globally.”