Renal Denervation: The Game Changer

Renal Denervation: The Game Changer

Maria Shepherd • Data Decision Group

Who knew that hypertension, a disease state formerly addressed only by pharmaceutical companies, could make such a great landing in the medical device world? Renal denervation is a disruptive, innovative new medical device perfectly poised to take enormous market share from the global anti-hypertensive drug market. The pharma market for anti-hypertensive drugs is forecast to exceed $66.2 billion by 2015.¹ Renal denervation currently is targeted toward high-risk patients that are resistant to hypertension drugs, but who knows what size this market will grow to during the next decade?

Why It’s Important
This is a perfect example of whitespace research at its finest. Prior to pharmacological management of hypertension, surgical sympathectomy (a procedure that destroys nerves) was a recognized treatment for hypertension.² The sympathetic nervous system (one part of the three-part autonomic nervous system) speeds the heart rate, constricts blood vessels, and raises blood pressure. The sympathetic nervous system can be described as the “fight or flight” system because it allows humans to respond to danger by fighting off an attacker or running away. When danger threatens, the system increases heart and respiratory rates and blood flow to muscles, and decreases blood flow to such other areas as skin, digestive tract and limb veins. The net effect is an increase in blood pressure.³

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Sympathectomy was successful in reducing blood pressure, but the side effects of the procedure were poorly tolerated. Modern antihypertensive pharmacological interventions have improved the control of hypertension, but an estimated 30 percent of hypertension cases are resistant. Renal denervation is the device-based solution to reducing hypertension. Renal denervation is a specialized ablation procedure that disrupts certain nerves in the kidneys, which results in a reduction of blood pressure.

The first device to be approved (European Union CE Mark in 2010) for renal denervation was the Symplicity Renal Denervation System, produced by Medtronic Inc. (formerly Ardian).^4,5 The Symplicity system consists of a steerable catheter with a radio frequency energy electrode tip and a generator.

During this minimally invasive procedure, the interventionalist uses the catheter to deliver radio frequency energy to the renal artery via femoral artery access. The ablations to each renal artery disrupt the nerves without the side effects of sympathectomy. Currently, no renal denervation device has U.S. Food and Drug Administration approval.

What are the Trends?
Researchers are examining medical devices and minimally invasive surgeries to help, such as devices that improve obesity-caused diabetes and other common disease states.























“I think we have to hit on all cylinders if we’re going to take on these very important diseases,” said Steven Nissen, M.D., chair of the Cleveland Clinic’s Department of Cardiology. “There are many examples where this convergence is taking place, where you push the drugs as far as you can, but when they can’t go any further, you step in with more invasive approaches.”⁸

The Opportunity
How many other large pharma markets can be converted to a device based approach? Whitespace research is critical to new market development, to examine every disease state for opportunity for a medical device solution to improve outcomes.

References:

1. www.strategyr.com/Anti_Hypertensive_Drugs_Market_Report.asp
2. Doumas, M; Douma, S (2009 Apr 11). “Interventional management of resistant hypertension.” Lancet 373 (9671): 1228-30.
3. www.surgeryencyclopedia.com/St-Wr/Sympathectomy.html.
4. Medtronic. About the Procedure. www.medtronicrdn.com/healthcare-professionals/about-rdn/about-the-procedure/index.htm [Accessed online June 28, 2012].
5. WhichMedicalDevice. Symplicity Catheter System (Overview). www.whichmedicaldevice.com/by-manufacturer/113/198/symplicity-catheter-system [Accessed online April 5, 2012].
6. circ.ahajournals.org/content/125/1/e2, AHA Heart Disease and Stroke Statistics, 2012.
7. Ibid.
8. www.huffingtonpost.com/2012/05/29/hypertension-destroy-nerves-high-blood-pressure_n_1552375.html.

Editor’s note: Readers are invited to submit market data and trend questions to Maria Shepherd. Periodically, selected questions will be presented in this column, with answers from Maria. Send your questions to the email in her bio (below).

Maria Shepherd, founder of Data Decision Group, has 20 years of leadership experience in medical device and life-sciences marketing. Following a career including serving as vice president of marketing for Oridion Medical; director of marketing for Philips Medical; and senior management roles at Boston Scientific Inc., she founded Data Decision Group. Her firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions for medtech companies. Shepherd teaches marketing and product development courses and recently was appointed to the board of the MSBiV Medtech Investment Committee. She can be reached at (617) 548-9892 and [email protected].