For the first time, St. Jude Medical Inc. ( STJ ) has won the U.S. Food and Drug Administration's (FDA) approval to commence the EnligHTN IV trial. The study will evaluate the efficacy of the company's EnligHTN Multi-Electrode Renal Denervation System in treating drug-resistant high blood pressure.
The randomized, single blind, controlled, multi-center will enroll 590 patients across 80 centers in the U.S. and Canada. Patients, aged between 18 and 80, with blood pressure of 160 mmHg or above in an office setting and already taking medications will be selected for the trial.
The emerging renal denervation business is a part of St. Jude's Cardiovascular and Ablation Technologies Division with major growth prospects. Hypertension affects more than 33% people in the U.S., according to the Centers for Disease Control and Prevention (CDC).
Renal denervation is a novel procedure, which has been developed for treating resistant hypertension and high blood pressure when patients do not respond well to conventional medical therapies. Physicians at St. Jude's cardiovascular unit believe that this alternative form of treatment for resistant hypertension represents a significant advancement in the field of medical science.
EnligHTN, the first multi-electrode ablation catheter in the medical device industry, treats hypertension by deactivating the nerves (which stimulate high blood pressure) adjacent to the renal arteries using a catheter-based probe. It enhances clinical accuracy and reduces procedural time at a much lower cost than drug therapy.
After receiving the CE Mark approval in May 2012, the device is commercially available in several markets. However, it is yet to receive an approval from the U.S. regulatory agencies. In addition to this trial, the company is conducting more renal denervation trials to establish the safety and reliability of the EnligHTN devices.
Data from the successful EnligHTN I study demonstrated that the EnligHTN system, reduced systolic blood pressure by 28 mmHg and 26 mmHg on an average in patients with resistant hypertension, after one month and six months of treatment, respectively.
St. Jude currently has a Zacks Rank #3 (Hold). Some of St. Jude's larger peers such as Medtronic ( MDT ), Boston Scientific ( BSX ) and Covidien ( COV ) are also major players in the renal denervation market. Medtronic is also conducting a U.S. IDE study for its CE-Marked Symplicity Catheter System.