St. Jude Medical (NYSE:STJ) this week announced that it launched its EnligHTN IV renal denervation study, the 1st U.S. trial evaluating the company’s EnligHTN system in treatment of drug-resistant high blood pressure under Investigational Device Exemption from the FDA.
St. Jude will enroll about 590 patients between the ages of 18 and 80 who have hypertension that isn’t well-managed with drugs, treating them with the EnligHTN Multi-Electrode renal denervation system.
The device applies radiofrequency energy to create tiny scars along nerves that control blood pressure. A multi-electrode catheter and newer energy generator (which wasn’t part of the EnligHTN IV trial) may cut procedure times from around 24 minutes apiece to 4 minutes, the company said.
The EnligHTN I through III trials took place in Australia, Greece, Europe and New Zealand, and the company recently presented positive 1-year results from the EnligHTN I trial at the annual EuroPCR meeting in Paris.
This month, the St. Paul, Minn.-based medical device company also began enrollment in the EnligHTN III trial,
"The EnligHTN IV study represents another important step in our commitment to advancing science, technology and clinical evidence that supports renal denervation for the millions of patients who live with uncontrolled high blood pressure," Frank Callaghan, president of St. Jude’s cardiovascular division, said in the statement.
Approximately 1 in 3 Americans has hypertension, or high blood pressure and this condition puts patients at high risk for heart attack, stroke and kidney failure, according to a company statement.
