Medtronic hits the reset button on its renal denervation program by launching two global studies to test its next-generation anti-hypertension therapy.  

Some physicians believe renal denervation is pretty much history.

After all, back in January 2014, the biggest trial of renal denervation conducted by Medtronic failed spectacularly in being unable to lower blood pressure in patients with resistant hypertension six months following the procedure. Soon after that announcement and well before its merger with Medtronic, Covidien too pulled the plug on its OneShot renal denervation program citing slow market growth in Europe.

But Medtronic is not giving up that easily.

The Irish medical device maker announced Wednesday that it has begun the SPYRAL HTN global clinical trial prpgram using the Symplicity Spyral catheter and Symplicity G3 radiofrequency (RF) generator. The program will involve two studies and both have been designed such that it can address the problems encountered in the original Symplicity HTN-3 trial.

It's not surprising that Medtronic is launching two studies using a next-generation system. After Medtronic announced that the Symplicity HTN-3 trial had failed, St. Jude Medical's CEO, Daniel Starks had briefly speculated that "the trial was done with a first-generation technology" with a catheter having a single electrode doing the job of neurostimulation.

Compare that to the Spyral device that Medtronic is testing which has multiple electrodes to provide mild electronic pulses to the renal artery.

"Medtronic believes the underlying science behind renal denervation is strong and that there is a clear unmet need for people with uncontrolled hypertension. Therefore, we remain committed to exploring the clinical potential of renal denervation in this population,” said Jason Weidman, vice president and general manager, Medtronic Coronary and Renal Denervation, within Medtronic’s Coronary and Structural Heart business, in prepared remarks. “To get to this point, we’ve performed extensive analyses and conducted additional pre-clinical testing following the SYMPLICITY HTN-3 trial. We’ve also consulted with the FDA and reimbursement bodies, and partnered with renowned thought-leaders worldwide to develop this novel clinical trial protocol.” 

It's important to note that neither of the two studies constitutes a pivotal trial, showing a deliberative, cautious approach. That's probably wise given how shocked the analyst community was when the pivotal trial of Symplicty HTN-3 failed given that they had all assumed the product would be approved based on great performance of the device in smaller studies before.

This time around the two studies will study the impact of renal denervation on patients who are currently taking anti-hypertension medication and patients who are off their medication. The studies will also enroll about 100 patients in 20 centers in the U.S. and abroad. Notably, the studies will evaluate renal denervation on patients with moderate- to high-risk hypertension instead of severe, drug-resistant hypertension.

Another difference is the number of medications that a patient enrolled in the second study that tests the therapy on patients currently taking medication. Whereas the failed trial had enrolled patients taking five drugs that control blood pressure, this time around, the trial will enroll patients who are on three drugs. Patients are also not required to be taking these drugs at their maximum dosage to qualify for enrollment.

"Studying patients both on and off medication in a less severe and more homogenous population than we saw in the SYMPLICITY HTN-3 trial is critical to gaining clarity on the true effect of this therapy,” said Dr. Raymond Townsend, director of the hypertension program, University of Pennsylvania in prepared remarks. “By specifying medication classes and not requiring maximum tolerated doses, we can expect medication variability to be reduced, which will allow for a more controlled assessment of the impact of renal denervation in the presence of medication.”

Based on the results of these two trials, Medtronic will determine the path to submitting a PMA submission to FDA and its equivalent agency in Japan.

Analysts have previously estimated the opportunity in renal denervation to be in the billions of dollars. 

Like Medtronic, St. Jude Medical also believes in the promise of the therapy. In September, the Minnesota medical technology company reported 12-month follow up data on patients who were treated with its multi-electrode catheter. part of it EnligHTN renal denervation system. The data shows that 78% of patients responded to the therapy.

Yet, the product is not doing well commercially in Europe and Australia where it launched in May 2012. The EnligHTN Renal Denervation System "continued to experience lower 2014 net sales ... compared to 2013 driven by expected overall market declines in the treatment of drug-resistant, uncontrolled hypertension," according to the company's 2014 annual report. 

Arundhati Parmar is senior editor at MD+DI. Reach her at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it  and on Twitter @aparmarbb 

[Featured Photo courtesy of iStockPhoto.com user Just_Human
 Product Image courtesy of Medtronic]

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DEERFIELD, Ill., Apr 01, 2015 (BUSINESS WIRE) -- Baxter International Inc. BAX, +0.68% today announced completion of CE marking (market approval) in Europe for HOMECHOICE CLARIA, an automated peritoneal dialysis (APD) system integrated with the SHARESOURCE web-based connectivity platform. The APD system is designed with user-friendly features and secure two-way connectivity so healthcare providers can have increased visibility to monitor their patients’ home peritoneal dialysis (PD) treatments and adjust prescriptions as necessary. PD is a therapy option performed primarily at home by end-stage renal disease patients.

''CLARIA builds upon our market-leading HOMECHOICE APD device with new features to make the system more intuitive for patients to operate in their home and while traveling,'' said Bruce Culleton, M.D., vice president, renal therapeutic area lead, Baxter. ''Additionally, SHARESOURCE, the system’s web-based platform, provides physicians remote access to their home patients’ treatment information allowing for more timely and personalized care.''

HOMECHOICE CLARIA with SHARESOURCE is also designed to save clinics time and improve healthcare practice efficiencies by reducing manual input of data and gathering both patient and clinic data into organized patient report dashboards that are easily accessed and viewed by healthcare providers. In addition, the HOMECHOICE CLARIA system features a large, two-line display screen for better visibility, and a universal interface that is available in 41 languages.

Baxter plans to initiate the commercial launch of HOMECHOICE CLARIA with SHARESOURCE in select European and Asian countries in the first half of 2015.

''Every patient with end-stage renal disease deserves access to individualized care,'' said Jill Schaaf, president of Baxter’s Renal business. ''HOMECHOICE CLARIA with SHARESOURCE represents Baxter’s continued commitment to advancing renal technology that offers healthcare providers and patients therapy options for end-stage renal disease.''

For prescription only. Forsafe and proper use of the devices mentioned herein, refer to the complete instructions in the Operator's Manual.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning Baxter’s HOMECHOICE CLARIA automated peritoneal dialysis system, including expectations with regard to future commercial launch plans. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply issues, or patient safety issues; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

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SOURCE: Baxter International Inc.

Baxter International Inc.
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Abstract and Introduction Medscape Multivariate-adjusted Cox regression revealed that antiviral treatment was associated with lower risks of ESRD (HR 0.15; 95% CI 0.07 to 0.31; p<0.001), ACS (HR 0.77; 95% CI 0.62 to 0.97; p=0.026) and ischaemic stroke (HR 0.62; 95% CI 0.46 to 0.83; ...

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