Feature | October 14, 2013

Renal Denervation Market: Impact of Major Barriers Underestimated by Industry Experts

renal denervation, Symplicity

An illustration of how renal denervation therapy is delivered, in this case using a Medtronic Symplicity device.

October 14, 2013 — Since its debut in 2010, the renal denervation market has generated enthusiasm across the medical device industry with predictions that the market would reach more than $1 billion by 2020.  However, the impact of major barriers, which will slow down this growth, was essentially underestimated according to an analyst with research and consulting firm GlobalData.

According to Joseph Gregory, GlobalData's analyst covering surgical devices, one of the most pressing barriers is reimbursement. Renal denervation has been approved in Europe since 2010 but has only seen full reimbursement in Germany and Austria as of 2013.

“The various European-run health insurance agencies are not entirely convinced of the long-term safety and efficacy of the procedure due to the lack of available data from sophisticated clinical trials. Currently, procedures in these countries are either being funded out of pocket or by a portion of hospital budgets dedicated toward the use of novel technologies,” said Gregory.

The establishment of a new referral pattern is another significant hurdle for the renal denervation market. Patients typically see their primary care physician first, and once uncontrolled hypertension is diagnosed, their physicians refer them to a hypertension specialist or cardiologist who will then make a final referral for the procedure.

“Medical device companies which specialize in interventional cardiology products have strong, established relationships with cardiologists, but their network does not extensively breach this first line of referral from primary care physicians. Thus, the sales and marketing teams of renal denervation companies have the difficult job of developing this network from scratch,” said Gregory.

The current state of the clinical trial data will also constrain the market, according to Gregory. While company-sponsored studies have to date proven short-term safety and efficacy, there is still ambiguity with regards to device performance in the long term, as well as the degree of efficacy that can be achieved.

“Further, looking at long-term procedure outcomes for renal denervation, there is very limited data available, as the longest follow-up to date is just three years, from Medtronic’s open-label, non-randomized Symplicity HTN-1 study,” said Gregory. “Overall, taking into consideration the full impact of these and numerous other market barriers, it is doubtful that renal denervation will prove to be the next blockbuster in the medical device industry.”

For more information: www.globaldata.com

Related Content

Cardioband, valtech, Edwards Lifesciences, transcatheter mitral repair, transcatheter tricuspid valve repair, transcatheter annuloplasty

An illustration of how the transcatheter Cardioband System can used as a non-surgical form on annuloplasty repair. 

News | Heart Valve Technology| December 02, 2016
December 2, 2016 — Edwards Lifesciences Corp.
Sponsored Content | Videos | Robotic Systems| November 22, 2016
Corindus Vascular Robotics received U.S.
Infinix-i Sky +, RSNA 2016, Toshiba, angiography systems

Toshiba Medical’s Infinix-i product line, including the Infinix-i Sky +, delivers patient access, image quality and safety features for virtually any image-guided procedure, including those in hybrid OR settings.

News | Angiography| November 21, 2016
November 21, 2016 – Healthcare providers seeking versatile imaging technology for their angiography needs can find a
News | Cath Lab| November 21, 2016
November 21, 2016 – A single-center study sponsored by the National Institutes of Health (NHLBI) failed to show an ea
Mitralign, Trialign System, tricuspid regurgitation, first transcatheter repair, cardiac implantable device lead, Piedmont
News | Heart Valve Technology| November 18, 2016
Mitralign Inc. announced the successful compassionate use treatment of a patient suffering from tricuspid regurgitation...
Sponsored Content | Videos | TCT| November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
Sponsored Content | Videos | Guidewires| November 18, 2016
A discussion with guidewire expert Dimitri Karmpaliotis, M.D., Ph.D., FACC, about the basics of interventional guidew
Sponsored Content | Videos | Heart Valve Technology| November 18, 2016
A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Tran
Sponsored Content | Videos | Heart Valve Technology| November 18, 2016
A discussion with Torsten Vahl, M.D., about advancements in transcatheter valve repair technology, including new devi
Sponsored Content | Videos | CT Angiography (CTA)| November 18, 2016
A discussion with Simon Dixon, M.D., MBChB, on the use of fractional flow reserve-computed tomography (FFR-CT) to eva
Overlay Init