Global medical device company St. Jude Medical Inc. (STJ) revealed new promising data from the EnligHTN I study at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The data indicated that the EnligHTN Multi-Electrode Renal Denervation System is capable of reducing systolic blood pressure by 24 mmHg (millimeters of mercury) on an average in patients with resistant hypertension, after 18 months of treatment.
Data from the initial EnligHTN I study had demonstrated that the EnligHTN system reduced systolic blood pressure by 28 mmHg and 26 mmHg on an average, after one month and six months of treatment, respectively.
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 conventional drug therapy.
After receiving the CE Mark approval in May 2012, the device was made commercially available in several markets. Further, the company developed an advanced next-generation EnligHTN Renal Denervation System, which reduces procedural time from 24 minutes to 4 minutes at a much lower cost than expensive drug therapy.
This device also earned the CE Mark in Aug 2013. However, both these devices are yet to receive an approval from the U.S. regulatory agencies. STJ is currently conducting 5 clinical trials on the EnligHTN devices.
Renal denervation is a novel procedure developed for treating resistant hypertension and high blood pressure in patients who do not respond well to conventional medical therapies. According to the World Health Organization (WHO), hypertension affects more than 33% people worldwide. 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.
Some of St. Jude’s larger peers such as Boston Scientific (BSX), Medtronic (MDT) and Covidien (COV) are also major players in the renal denervation market. At the TCT conference, Boston Scientific presented new interim data from its REDUCE-HTN study. The results demonstrated that 85% of the patients treated with the Vessix System experienced significant and sustained blood pressure reduction. BSX carries a Zacks Rank #2 (Buy).
In Sep 2013, Medtronic had announced encouraging final results from the first and the longest-running Symplicity HTN-1 three-year study, for its CE-Marked Symplicity Catheter System. In early 2013, Covidien had launched its CE-Marked OneShot Renal Denervation System in Europe and other select markets viz. Middle East, Africa, Asia and Latin America. MDT carries a Zacks Rank #2 (Buy), while COV has a Zacks Rank #3 (Hold).
St. Jude presently has a Zacks Rank #3 (Hold). The company recently posted strong third-quarter results, which beat the Zacks Consensus Estimate at both fronts. Gradual improvement in the beleaguered core CRM business is encouraging. New products from fresh acquisitions should propel the top line further in the near term. Moreover, the company has raised its adjusted earnings expectations for the year to the band of $3.72–$3.74 per share from the earlier guidance range of $3.70–$3.73 a share.
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