|Medtronic is looking to study how Symplicity can help patients with less severe hypertension.--Courtesy of Medtronic|
Medtronic ($MDT) is seeking the FDA's blessing for another study of its renal denervation device, this time targeting patients with less severe hypertension, a move that could spell a broader indication once the device is approved.
The company has filed an Investigation Device Exemption with the agency, and, if the FDA says yes, Medtronic will kick off its fourth study of the Symplicity device.
The new trial, dubbed Symplicity HTN-4, would build upon the results of Medtronic's ongoing large-scale U.S. pivotal trial of patients with systolic blood pressure above 160 mm Hg, this time looping in patients with readings between 140 and 160 mm Hg. Medtronic plans to start enrollment for the new study in the second half of this year, and the company has said it expects to get Symplicity approved by the FDA in 2015.
"Symplicity HTN-4 demonstrates Medtronic's commitment to providing randomized safety and efficacy data for renal denervation in a wide variety of patients, as well as help increase our understanding of the potential benefit of renal denervation on patients with a less severe form of treatment-resistant hypertension," Medtronic Senior Vice President Sean Salmon said in a statement.
Analysts project the market for renal denervation devices to soar close to $3 billion over the next decade, and much of that optimism rides on the technology getting indicated for more than just the most-dire cases of hypertension. Medtronic joins St. Jude Medical ($STJ) and its EnligHTN device in studying how well the treatment works in broader swathes of the population, all with the goal of marketing the tech to as many patients as possible.
The latest trial would also feed into Medtronic's ocean of data for Symplicity, as the company has thus far enrolled more than 5,000 patients in its global registry, planning to use 5-year results to study not just blood pressure reduction but also rates of stroke, myocardial infarction, heart failure and cardiovascular death.
- read Medtronic's announcement
Special Report: Renal Denervation - The Next Big Thing in Medical Devices