Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts

Dive Brief:

Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month.
The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system.
While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market.

Dive Insight:

Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development for a field that was previously set back by a major failure, cardiologists continued to see value in the procedure.

The renal denervation field is now weeks away from learning what the cardiologists and other experts on the FDA’s circulatory system devices panel make of the data. Ahead of the meeting, which is scheduled for Aug. 22 and 23, the team at Needham looked at the likely topics of debate and predicted a win for Medtronic.

“We believe that the clinical trials have largely supported the safety and efficacy of RDN. However, RDN is not without controversy,” the analysts wrote. “Overall, we think it's likely that the panel will support Symplicity Spyral's safety and efficacy.”

The analysts identified six likely areas of discussion: the failure of Medtronic’s pivotal trial; whether renal denervation's blood pressure improvement is large enough to justify the procedure; renal denervation's ability to lower the rate of cardiovascular events; selecting patients who are most likely to benefit; appropriate indications for renal denervation; and the longer-term safety and durability of the procedure.

A lot is resting on the outcome of the meeting. Medtronic has predicted that the market could be worth $500 million by 2026 and $2 billion to $3 billion by 2030. The Needham analysts noted that renal denervation is “a new technology and lacks established reimbursement” and, as such, they “expect it to take time for the market to develop and ... sales to be limited for the first few years.”

Medtronic has identified the 2 million patients with uncontrolled resistant hypertension who are taking three or more medicines as the initial patient population for the treatment. Beyond that, the company hopes to expand into a broader group, targeting more than 100 million patients.