A Medtronic Inc. device that attempts to lower high blood pressure showed promising results in a clinical trial after six months.
The Fridley-based medical technology giant said it will present the data to doctors and researchers at the meeting of the European Society of Hypertension's annual meeting on Friday. Medtronic's Symplicity Catheter System treats high blood pressure in a minimally invasive procedure that deploys low-power radio frequency energy on the renal arteries near each kidney. The procedure does not require a permanent implant.
The Symplicity trial is an international, multi-center, randomized, controlled study of the safety and effectiveness of renal denervation in patients with treatment-resistant high blood pressure. One-hundred and six patients were enrolled at 24 sites.
At six months, both randomized and crossover patients in the study who underwent renal denervation with the Medtronic device showed "significant, sustained blood pressure reduction," the company said.
The device is not approved for use in the United States, but is currently available in parts of Europe, Asia, Africa, Australia and the Americas. Regulators last year gave Medtronic the go-ahead to conduct a 530-patient clinical trial in the United States at 90 sites.
More than 1.2 billion people worldwide suffer from high blood pressure, and medication fails to work in treating many of them.
Medtronic acquired the technology earlier this year through its $800 million purchase of Mountain View, Calif.-based Ardian Inc., a privately held company that developed the system. Additional cash payments tied to Symplicity's annual revenue growth through fiscal 2015 also were part of the deal. Janet Moore • 612-673-7752