Medtronic investors celebrated the announcement of potential Medicare coverage for a procedure that treats hypertension with the company's Symplicity device, lifting company stock more than 4% Tuesday.
The medtech company, run from offices in Fridley, revealed Monday night that the Centers for Medicare and Medicaid Services (CMS) is creating a national coverage analysis of the procedure, called renal denervation. The analysis may lead to Medicare covering the catheter procedure by October, if not earlier.
"Our Symplicity blood pressure procedure," CEO Geoff Martha said at the JPMorgan Healthcare Conference on Monday, "is poised to transform hypertension management, and it's a large opportunity that's right in front of us — and I really mean right in front of us."
Hypertension, occurring when pressure in blood vessels is too high, affects over a billion people worldwide. A 1% market penetration with the procedure would amount to a billion dollars of revenue, Martha said. Half of all heart disease and stroke deaths are caused by hypertension, he said.
The company's stock rose 4.2% on Tuesday. In the last three months, it had dropped 4.6%.
Vijay Kumar, an analyst at Evercore, attributed the stock price rise to the clearing of reimbursement hurdles that has slowed clinical uptake of the procedure.
People often take medications for hypertension, but they can stop working over time, said Jason Fontana, Medtronic vice president and general manager of renal denervation. Patients might stop taking the medications, which can contribute to death or stroke.
Fontana said the procedure with the Symplicity device takes roughly one hour and uses a catheter, a thin tube-shaped device physicians can advance to the through blood vessels, allowing access to the renal arteries near the kidneys without open surgery. Doctors interrupt signals of the nerves in the renal arteries to reduce the effects of the body's fight-or-flight system, decreasing blood pressure.
The procedure is already occurring, Fontana said, with hospitals footing the bill or insurers covering it through the prior authorization process.
Fontana said in an interview the analysis "basically says to us that CMS is committed to covering the use of the spiral catheter in patients with hypertension."
Private insurers often wait until Medicare covers a device to also extend wide coverage.
The CMS analysis is huge news for patients and marks a development in Medtronic's efforts to support access to the procedure, Martha said.
The device has a long history, Kumar said. An initial trial failed roughly a decade ago, then the pandemic further complicated study of the procedure, he said.
"It's been a roller coaster ride for sure for investors," Kumar said in an interview.
Martha said the company has renewed its commitment to innovation and streamlined its operating model in the last ten years.
"We've got a lot of momentum right now at Medtronic," Martha said, adding the company has a tailwind for the first time in a while.