St. Jude Medical Inc. has initiated the EnligHTN III trial with the enrollment of the first patient to evaluate its latest, second-generation EnligHTN Renal Denervation System in treating drug-resistant, uncontrolled hypertension. This non-randomized trial will enroll up to 50 people in Australia and New Zealand.
Hypertension affects more than 33% people worldwide, according to the World Health Organization (WHO). 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.
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. The first-generation EnligHTN device already received the CE Mark approval in May 2012 and is commercially available in several markets.
The second-generation EnligHTN is an advanced version with a new generator capable of delivering simultaneous ablations using four electrodes via a high-tech touch screen. It also allows doctors to observe and record information during procedures. As a result, it enhances clinical accuracy and reduces procedural time - from 24 minutes to 4 minutes - at a much lower cost than expensive drug therapy. However, both the devices are yet to receive an approval from the U.S. regulatory agencies.
The emerging renal denervation business is a part of St. Jude’s Cardiovascular and Ablation Technologies Division and represents major growth prospects. 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.
Currently, St. Jude is also conducting the EnligHTN II and the EnligHTNment studies for its renal denervation system. The former further broadens the scope of the EnligHTN I trial and the latter is analyzing the effectiveness of EnligHTN in reducing major cardiovascular events such as strokes, heart attacks and deaths, in addition to lowering blood pressure.
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 and six months of treatment, respectively.
Some of St. Jude’s larger peers such as Medtronic (MDT - Free Report) and Boston Scientific (BSX - Free Report) 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.
St. Jude currently carries a Zacks Rank #3 (Hold). While we remain on the sidelines regarding STJ as its core CRM division is still underperforming, other medical stocks such as Conceptus carrying a Zacks Rank #1 (Strong Buy), warrants a look.