STJ ST. Jude Medical, Inc.

Leading medical devices player, Medtronic (MDT), has received conditional approval from the US Food and Drug Administration (FDA) for a US clinical trial called Symplicity HTN-3. The clinical trial will involve renal denervation with Symplicity catheter system for the treatment of resistant hypertension (high blood pressure that could not be controlled with drugs). The device has already been approved in both Europe and Australia.

The Symplicity HTN-3 study will assess the effectiveness and safety of renal denervation with the Symplicity catheter system. The study aims to enroll approximately 500 patients across 60 US medical centers. The patients will be randomized to receive either renal denervation along with anti-hypertensive medications or treatment with anti-hypertensive medications alone. Primary endpoints of the study include change in blood pressure from baseline after six months and occurrence of major adverse events after one month of treatment.

Clinical studies till date have demonstrated that renal denervation with the Symplicity catheter system results in significant reduction in blood pressure levels for many patients, who were unable to check blood pressure despite multiple medications. Results from Symplicity HTN-2 trial, carried out with 106 patients in Europe, Australia and New Zealand were favorable. It was observed that patients undergoing renal denervation experienced reduction in blood pressure, whereas blood pressure for those in the control group (who received only anti-hypertensive medications) did not vary. Moreover, adverse events were similar between the groups.

The Symplicity catheter system was included in Medtronic’s portfolio with the acquisition of Ardian.  The decision to acquire Ardian was based on the thesis that renal denervation as a treatment for uncontrolled hypertension has the potential to record strong growth going ahead. Immense potential exists in this market as hypertension, affecting about 1.2 billion people, is one of the leading causes of death globally.

The fiscal 2011 has been one of the most challenging years for Medtronic based on macroeconomic downturn, decreased utilization and increased payer pushback. Although the situation is improving gradually, the two biggest segments of the company – CRDM and Spinal continue to remain under pressure. Meanwhile, Medtronic is increasing its focus on emerging markets and emerging therapies and expects these to be major growth drivers going ahead. The company also faces tough competition from players such as Boston Scientific Corporation (BSX) and St. Jude Medical (STJ).

 
BOSTON SCIENTIF (BSX): Free Stock Analysis Report
 
MEDTRONIC (MDT): Free Stock Analysis Report
 
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
 
Zacks Investment Research