|Medtronic is studying its Symplicity device on patients with less-severe hypertension.--Courtesy of Medtronic|
Medtronic ($MDT) leads the way among companies working to get much-hyped renal denervation devices on the U.S. market, and now the med tech heavyweight is working to broaden the horizons for its hypertension-treating technology, embarking on a study for patients with less-severe cases.
The latest study will test how well Symplicity can treat patients with systolic blood pressure between 140 mmHg and 160 mmHg, making it the first randomized U.S. trial to study renal denervation in milder hypertension. Dubbed Symplicity HTN-4, the study will build on data from an ongoing U.S. trial in patients with blood pressure readings north of the 160-mmHg mark, enrolling up to 580 patients with the goal of supporting a wider indication when Medtronic makes its case to the FDA next year.
"Symplicity HTN-4 demonstrates Medtronic's commitment to providing randomized safety and efficacy data for renal denervation in a wide variety of patients, as well as helping increase our understanding of the potential benefit of renal denervation for more patients with treatment-resistant hypertension," Medtronic Vice President Nina Goodheart said in a statement.
Meanwhile, St. Jude Medical ($STJ), Medtronic's closest competitor in the space, pulled the plug on a similar study earlier this month after struggling with enrollment in an effort to test its EnligHTN device in the same patient population. Boston Scientific ($BSX) and Covidien ($COV) lag behind the two Minnesota giants.
HTN-4 makes for a total of 9 Symplicity studies around the world, including Medtronic's pivotal U.S. trial, which is now in the patient follow-up stage. The Symplicity program also includes a study in India, one in Japan and one for the next-generation Symplicity Spyral.
Medtronic expects to churn out pivotal data on the device in the first half of next year, and the company is still on track for an expected 2015 FDA approval, which would make it the first on the U.S. market. Analysts project peak sales of as much as $3 billion for renal denervation technologies.
- read the announcement