St. Jude Medical Inc. ( STJ ) commenced the EnligHTNment trial study at the EuroPCR to analyze the effectiveness of its EnligHTN Multi-Electrode Renal Denervation System in reducing major cardiovascular events such as strokes, heart attacks and deaths in addition to lowering blood pressure. The first-of-its kind prospective, randomized, controlled clinical trial will enroll about 4,000 patients across 150 centers globally and will be monitored for 5 years.
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 1 billion people worldwide, according to the World Health Organization (WHO). Almost 13% of all deaths occur due to uncontrolled blood pressure, including 51% as a result of stroke and 45% due to heart ailments.
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.
The device received the CE Mark approval in May 2012 and is commercially available in several markets. However, it is yet to receive an approval from the U.S. regulatory agencies. In addition to the EnligHTNment trial, the company is conducting two more renal denervation trials viz. EnligHTN II and EnligHTN III to study the safety and efficacy of the EnligHTN systems (both old and new) in reducing uncontrolled hypertension.
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 conducting a U.S. IDE study for its CE-Marked Symplicity Catheter System. Boston Scientific acquired Vassix Vascular in the fourth quarter of 2012, a developer of percutaneous radiofrequency balloon catheter technology for the treatment of hypertension.
In Jan, 2013, Covidien rolled out its OneShot Renal Denervation System, used to treat hypertension. The vascular therpeutics device received CE Mark approval in early 2012. It will be launched in EMEA and Latin America soon and is currently undergoing clinical trials in Europe and New Zealand.