As a boost to its efforts to expand its coronary business globally, Medtronic Inc. (MDT) received CE Mark (Conformité Européenne) in Europe and Therapeutic Goods Administration (TGA) listing in Australia for two of its Symplicity line of products.
According to the company, during renal denervation procedures for patients with uncontrolled hypertension, these two systems, viz. 4 Fr multi-electrode Symplicity Spyral catheter and Symplicity G3 radio frequency (RF) generator, are expected to substantially reduce ablation time and provide ease of deliverability.
Uncontrolled hypertension is directly linked with a high risk of heart attacks, stroke, heart failure, kidney disease and even death. Under traditional therapy, patients are prescribed with 3-5 classes of anti-hypertensive medications that can have a number of side effects.
Given almost 120 million high blood pressure patients worldwide suffering from uncontrolled hypertension, with systolic blood pressures at or above 140 mm Hg, we remain confident about the global market adoption of this new system, given that it hardly has any side effect.
In renal denervation, Medtronic is currently investing in developing referral networks, reimbursement, technology development, and clinical and economic evidence to further strengthen its leadership position and grasp the long-term opportunity in hypertension treatment.
Currently, the company is perusing research and development in renal denervation worldwide and has many ongoing clinical studies. Last month, the U.S. Food and Drug Administration (:FDA) approved an Investigational Device Exemption (IDE) allowing Medtronic to initiate SYMPLICITY HTN-4, the first randomized trial to investigate renal denervation for the treatment of moderate uncontrolled hypertension in patients in the U.S. This is presently available only for investigational use in the country.
The study will evaluate the Symplicity renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure greater than or equal to 140 and less than 160 mm Hg, despite being administered to treatment with three or more anti-hypertensive medications of different classes).
Moreover, the Symplicity HTN-3 U.S. pivotal study – the first and only pivotal U.S. clinical trial of the Symplicity renal denervation system for uncontrolled hypertension, completed enrollment of 535 patients across nearly 90 U.S. medical centers in May 2013. The results are expected to be available during the first half of 2014.
Currently, Medtronic carries a Zacks Rank #3 (Hold). Better-ranked medical device stocks such as Hill-Rom Holdings, Inc. (HRC), Natus Medical Inc. (BABY) and NuVasive, Inc. (NUVA) are also expected to do well. While Hill-Rom and Natus Medical sports a Zacks Rank #1 (Strong Buy), NuVasive holds a Zacks Rank #2 (Buy).