(STJ) St. Jude Medical Begins EnligHTN II Trial

St. Jude Medical Inc. (STJ) has initiated the EnligHTN II trail with the enrolment of first patient to further evaluate its renal denervation technology in treating uncontrolled hypertension. This follows the successful EnligHTN I trial presented at the 2012 American Heart Association (AHA) meeting.

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.

Positive data from the EnligHTN I study had demonstrated that systolic blood pressure dropped by 28 mmHg points on an average in patients with drug-resistant hypertension. Moreover, it remained stable after six months of treatment with a reduction of 26 mmHg points. This was a landmark finding based on the fact that the risk of cardiovascular death falls by 50% with every 20 mmHg drop in systolic blood pressure.

The latest EnligHTN II (IntErnational non-randomized, single-arm, long-term follow-up study of patients with uncontrolled HyperTensioN) trial further broadens the scope of the study and aims to observe a broader patient population for six months after renal denervation. The study will be held at 40 medical centers across Europe and Australia and will enroll roughly 500 patients with uncontrolled hypertension.

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 expensive 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.

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.

Earlier, one of St. Jude’s larger peers in this space, Medtronic (MDT), posted encouraging data from a randomized study called Symplicity HTN-2. The study evaluated the company’s Symplicity renal denervation system. Medtronic expects the U.S. launch of the system for treatment-resistant hypertension in fiscal 2015.

Another, large-cap medical devices company, Boston Scientific (BSX), is planning to acquire Vessix Vascular, which developed the percutaneous radiofrequency balloon catheter technology for the treatment of hypertension.

We currently have a Zacks Rank #3 (Hold) on St. Jude. The company’s fourth-quarter adjusted earnings per share of 92 cents (up 7% year-over-year) topped the Zacks Consensus Estimate by 2 cents. Medical products companies such as Nuvasive Inc. (NUVA), which carries a Zacks Rank #1 (Strong Buy), is expected to do well.

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