Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S.
The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary tension with associated heart failure. Paris, France-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina.
Dr. Marat Fudim and Dr. Richard Krasuski enrolled the first patient at Duke.
“We are excited to enroll the first US patient in this important study,” Fudim said in a news release. “Completion of this study is a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.”
PreVail-PH2 is enrolling patients with pulmonary hypertension due to left-sided heart disease. According to Gradient, no approved drug or device therapy exists for this group of pulmonary hypertension patients.
Renal denervation became a hot-button topic in recent years, with Medtronic and ReCor Medical both winning major approvals last year. However, those approvals enabled an adjunctive treatment option when lifestyle changes and medications fail to adequately control a hypertension patient’s blood pressure.
Gradient designed its system to ablate nerves around the pulmonary artery using therapeutic ultrasound energy. It down-regulates the sympathetic nervous system’s input into the pulmonary vascular tree, reducing vascular resistance and lowering pulmonary pressures.
The company closed a $15 million Series A for its catheter-based technology last September.
“We are thrilled to initiate this study and bring our technology to patients in the United States,” said Martin Grasse, Gradient CEO. “We look forward to continuing to work with the FDA and our clinical partners as we enroll this study.”
