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After Medtronic’s latest setback, what’s next for Symplicity Spyral RDN?

Medtronic’s Symplicity Spyral device is a multi-electrode radiofrequency catheter for renal denervation. [Image courtesy of Medtronic]

Medtronic’s Symplicity Spyral renal denervation (RDN) system for treating hypertension seems less likely now than ever to win FDA approval after yesterday’s vote Circulatory Systems Devices Panel vote.

The panel’s medical and statistical experts voted against recommending approval of Medtronic’s RDN therapy for hypertension under the proposed indications. While they supported approval of ReCor Medical’s competing RDN system one day earlier, a key difference was the failure of Medtronic’s RDN system to outperform hypertension drugs.

Medtronic acquired the technology through its takeover of Ardian in January 2011. Early clinical results were promising, but Medtronic announced in 2014 that its Symplicity HTN-3 trial failed to meet it…

FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation catheter delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic faced tough questions about its Symplicity Spyral renal denervation (RDN) therapy for hypertension at today’s FDA review panel.

Medtronic is seeking approval of its Symplicity Spyral multi-electrode RDN catheter and Symplicity G3 radiofrequency generator “for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of anti-hypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

The stakes are high for Medtronic, which has been developing the technology for years in the belief that it could be a billion-dollar business and provide relief to millions of patients worldwide, reducing heart attacks, strokes and other seriou…

Ahead of Medtronic RDN’s FDA review panel, analysts place their bets

The Symplicity Spyral renal denervation system delivers radiofrequency energy via a catheter to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Analysts expect good news for Medtronic and its renal denervation (RDN) therapy for hypertension when the FDA review panel meets later this month.

RDN therapy could be a life-saver for millions of patients with high blood pressure — and a billion-dollar business for Medtronic if it wins FDA approval after two failed trials in the past decade.

The world’s largest medical device company is looking for a win after the latest RDN pivotal trial fell short of expectations, a disappointing result in a year with many other challenges. Medtronic’s revenue slipped 1% in fiscal 2023 (which ended on April 28, 2023), and net income dropped by 25% year-over-year as the company cut costs with early retirements, la…

CMS puts final nail in MCIT payment proposal for breakthrough devices

The U.S. Centers for Medicare & Medicaid Services (CMS) rescinded the Medicare Coverage of Innovative Technology (MCIT) and definition of “Reasonable and Necessary” final rule today.

CMS said it intends to explore ways to improve the coverage process for better access to innovative and beneficial medical devices, including a process for the Medicare program to cover new technologies based on scientifically sound clinical evidence and health and safety protections.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a news release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

The rule would have authorized government payments for medical devices designated as breakthroughs…