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St. Jude Medical Reports Positive EnligHTN Data

Zacks Equity Research

St. Jude Medical Inc. (STJ) recently announced preliminary results from its EnligHTN III study. The results demonstrate the effectiveness of the company’s second-generation EnligHTN renal denervation system in treating patients with drug-resistant, uncontrolled hypertension for a period of six months post the renal denervation procedure.

The results were declared during a hot line late-breaking clinical trial session at EuroPCR 2014. Following the announcement, shares of St. Jude Medical rose 0.9% to close at $64.15 yesterday.

The EnligHTN Renal Denervation System

Renal denervation is a catheter-based ablation procedure used to treat patients with drug-resistant hypertension (high blood pressure). The next-generation EnligHTN system delivers radiofrequency energy from an ablation catheter to create lesions (tiny scars) along the renal nerves – a network of nerves in the walls of the renal arteries. The intentional disruption of the nerve supply has been clinically found to help reduce blood pressure.

The system also offers physicians with a multi-electrode catheter which has an intuitive and fast generator that quickly and effectively delivers consistent ablations thus reducing procedure time significantly.

The EnligHTN Study

The EnligHTN III study is an international, non-randomized clinical trial conducted to assess the performance of St. Jude Medical’s renal denervation system in treating hypertension. The study enrolled 39 patients who suffer from high blood pressure which cannot be controlled through medication. The trial followed device performance and evaluated outcomes through six months of follow-up.

The EnligHTN III study expands upon the research conducted in the EnligHTN I trial of the first-generation EnligHTN system. The EnligHTN I multicenter study registered 46 patients.

Currently, the EnligHTN II Trial is being conducted at up to 40 sites in Europe and Australia and will register up to 500 patients with uncontrolled hypertension.

Collectively, the EnligHTN trials are approaching 300 treated patients with ongoing enrollments in the EnligHTN II trial and observational registries across Europe and Australia.

EnligHTN Data

Six-month EnligHTN III data confirms the benefits associated with St. Jude Medical’s EnligHTN Renal Denervation System. The information showed that 81% of the patients responded positively to the therapy, with a blood pressure reduction of at least 10 mmHg. The study recorded an average systolic blood pressure reduction of 25 mmHg points and no serious device- or procedure-related adverse events were reported.

New data from the EnligHTN I trial was also presented at EuroPCR 2014. The data confirmed that fast and early reduction in blood pressure remains sustained at 24 months, clearly indicating the long-term benefits of the EnligHTN technology.

Also presented at EuroPCR 2014 were one-month findings from the post-market EnligHTN II clinical trial. Preliminary results from the trial demonstrated a reduction in systolic blood pressure across sub-groups with varying degrees of hypertension and kidney functionality.

Going Forward

Results from the EnligHTN I, II and III trials presented during EuroPCR add to the growing body of clinical evidence supporting the benefits of EnligHTN renal denervation technologies.

St. Jude Medical is encouraged by the positive clinical results from the EnligHTN trials. The company uses internal product development capabilities to optimize its multi-electrode renal denervation technology. It continues to invest in renal denervation as a potential long-term growth driver.

St. Jude Medical currently carries a Zacks Rank #3 (Hold). Some better-ranked medical product stocks include Cardica Inc. (CRDC), Eagle Pharmaceuticals Inc. (EGRX) and Mead Johnson (MJN). All these stocks retain a Zacks Rank #2 (Buy).

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