Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

St. Jude Plans Trial To Study Renal Denervation Outcomes

This article was originally published in The Pink Sheet Daily

Executive Summary

Landmark trial will evaluate whether reductions in blood pressure caused by renal denervation translate to clinical improvements in patients with hard-to-treat hypertension.

St. Jude Medical Inc. is sponsoring a landmark clinical trial to evaluate the clinical benefits of reducing hypertension with its EnligHTN renal denervation system.

The EnligHTNment trial will evaluate outcomes of patients with uncontrolled hypertension treated with EnligHTN to determine whether renal denervation can significantly reduce the risk of heart attack, stroke and death, Frank Callaghan, the president of St. Jude’s Cardiovascular and Ablation Technologies Division, told “The Gray Sheet.”

“There is a well-established connection between uncontrolled hypertension and the risk of heart attack, stroke and death,” Callaghan said. “Through the EnligHTNment trial we hope to learn if lowering blood pressure through this minimally invasive procedure also lowers the risk of these major cardiac events.”

St. Jude declined to provide specifics on how many patients the EnligHTNment trial expects to enroll, or where it will take place.

Callaghan pointed out that the patients in EnligHTNment will be the same type of uncontrolled hypertension patients enrolled in the EnligHTN II trial, which is measuring the mean reduction in systolic blood pressure six months after the renal denervation procedure. (See (Also see "Research In Brief" - Medtech Insight, 4 Feb, 2013.).) Both studies build on the results of the EnligHTN I trial, which showed an average reduction in systolic blood pressure of 28 mmHG one month after renal denervation treatment in patients with drug-resistant hypertension. This improvement was sustained six months after the procedure. (See (Also see "New Products In Brief" - Medtech Insight, 21 May, 2012.).)

St. Jude is also planning the EnligHTN III feasibility trial of the second-generation EnligHTN system, which will set the stage for the EnligHTN IV pivotal U.S. trial to begin in the second half of 2013. This trial will be the basis for an eventual FDA application, according to the firm. The second-generation device has a new radiofrequency generator touch screen interface that St. Jude expects will encourage adoption of the technology because it will dramatically shorten the procedure time, Callaghan said.

St. Jude Tries To Take Lead In Potentially Big Race

EnligHTN is a multi-electrode radiofrequency ablation catheter that burns lesions along the renal sympathetic nerves, which regulate blood pressure.

“St. Jude Medical has a long history in ablation technologies for cardiac arrhythmias. We have been able to leverage technologies and expertise to optimize costs, quality and speed-to-market in our renal denervation program,” Callaghan said.

The system’s non-occlusive basket with multiple electrodes delivers a predictable pattern of four evenly spaced ablations with each catheter placement, he said.

“By having multiple electrodes, the EnligHTN system has the potential to improve consistency of ablations and save time. Most systems only feature a single electrode, which means the physician has to perform a single ablation and then move the electrode to perform the next ablation.”

St. Jude launched the first-generation EnligHTN system in Europe during the first half of 2012 and expects to launch the second-generation version in Europe in the middle of 2013.

Medtronic Inc.’s Symplicity, ReCor Medical’sParadise and Medtronic Minimally Invasive Therapies’s OneShot are also available in Europe. Boston Scientific Corp. is targeting the second half of 2013 for a European launch of the V2 renal denervation catheter. (See (Also see "Boston Scientific Enters Renal Denervation Market Via Vessix Acquisition" - Medtech Insight, 12 Nov, 2012.).) Medtronic is planning to launch Symplicity in the U.S. in 2014. (See (Also see "With Trial Approval, Medtronic Aims For Symplicity RF Catheter Launch In 2014" - Medtech Insight, 18 Jul, 2011.).)

During St. Jude’s Feb. 1 investor meeting, Callaghan pointed out that there are about 300 million patients worldwide being treated for hypertension, which includes an “uncontrolled” group, including patients who cannot tolerate the drugs or keep up with the necessary drug regimen.

“It's a large population,” he said. “If you assume only a 4 percent penetration into that treated and uncontrolled group, you get a multi-tens-of-billions-dollar opportunity.”

St. Jude cites World Health Organization estimates showing that about 13 percent of all deaths, including about half of deaths caused by stroke or coronary disease, are attributable to high blood pressure.

[Editor’s note: This story was contributed by “The Gray Sheet,” your source for in-depth coverage of the medical device and diagnostics industry. For more information call 1-800-332-2181. To register for a free trial, click here/ – no credit card needed.]

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075318

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel