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

Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
statins, heart disease, HOPE-3 trial, intermediate-risk patients, hypertension, ACC.16
News | Pharmaceuticals| April 20, 2016
Lowering cholesterol with statins significantly reduced adverse cardiovascular events in people with average...
Boston Scientific, Fetch 2 aspiration catheter, Class 1 recall
News | Thrombectomy Devices| April 20, 2016
April 20, 2016 — Boston Scientific Corp. announced a U.S.
ischemic postconditioning, STEMI patients, clinical outcomes, ACC.16
News | Cath Lab| April 19, 2016
A large randomized controlled trial of ischemic postconditioning in patients who had experienced ST-segment elevation...
STEMI, delayed or deferred stent implantation, DANAMI-3-DEFER trial, ACC.16
News | Cath Lab| April 18, 2016
Delayed or deferred stent implantation in patients showed no clinical benefit in patients experiencing the deadliest...
ACR, American College of Radiology, MEDCAC, peripheral arterial disease, PAD, seniors
News | Peripheral Arterial Disease (PAD)| April 18, 2016
The American College of Radiology (ACR), as a member of a coalition of leading medical societies, provided peripheral...
Overlay Init