St. Jude Medical Inc. has initiated a multi-center, randomized controlled study to analyze the effectiveness of its EnligHTN Renal Denervation System in reducing major cardiovascular events such as strokes, heart attacks and deaths in addition to lowering blood pressure. The EnligHTN trial will be a large-scale, multi-center, randomized controlled study, representing the first-of-its kind clinical trial in the renal denervation medical devices market.
The emerging renal denervation business is a part of St. Jude’s Cardiovascular and Ablation Technologies Division with major growth prospects. In addition to the EnligHTNment trial, the company is conducting two more renal denervation trials viz. EnligHTN I and EnligHTN II to study the safety and efficacy of the EnligHTN system
Hypertension affects more than 33% 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 already 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. St. Jude’s peer, Medtronic (MDT - Free Report) expects the U.S. launch of its Symplicity renal denervation system for treatment-resistant hypertension in fiscal 2015. The company posted encouraging data from a randomized study called Symplicity HTN-2, evaluating the aforementioned device.
St. Jude currently has a Zacks Rank #3 (Hold). While we remain on the sidelines regarding St. Jude, medical products companies such as Nuvasive Inc. (NUVA - Free Report) and ResMed Inc. (RMD - Free Report) with Zacks Rank #1 (Strong Buy), are expected to do well.