According to the Mayo Clinic, percutaneous renal artery sympathetic denervation (“RDN”) is a procedure used to perform circumferential radiofrequency ablation of the renal arteries. Percutaneous renal artery sympathetic denervation has already been used on patients with resistant hypertension in clinical trials and later in clinical practice in Europe. While RDN remains investigational in the United States, Medtronic and St. Jude Medical have the SymplicityTM and EnligHTN devices, respectively, which are CE mark approved in Europe and are in clinical trials in the U.S. Other device makers with CE-mark approved RDN devices include Covidien, which acquired Maya Medical in 2012 for $60 million; Boston Scientific, which acquired Vessix Vascular in 2012 for $425 million; ReCor; and Terumo. An October 2013 report on Market Realist states that analysts estimate that the global RDN market will increase at a compound annual growth rate of 42% from 2012 to 2016.
According to Medtronic’s website, Medtronic’s SymplicityTM RDN system consists of a catheter and a generator. The SymplicityTM catheter is placed in the vasculature adjacent to the target neural site and delivers radiofrequency energy to the target nerves. The radiofrequency energy is delivered to the SymplicityTM catheter from the SymplicityTM generator.
On January 14, 2014, Medtronic announced that its U.S. pivotal trial in renal denervation for treatment-resistent hypertension, SYMPLICITY HTN-3, failed to meet its primary efficacy endpoint. According to Medtronic’s press release, its U.S. pivotal trial was the first blinded, randomized, controlled trial. Although the trial met its primary safety endpoint, it failed to meet its primary efficacy endpoint. As a result, Medtronic will convene a panel of independent advisors to make recommendations about the future of Medtronic’s global hypertension clinical trial program. Pending this review, Medtronic says that it plans to suspend enrollment in ongoing clinical trials in the U.S. (SYMPLICITY HTN-4), Japan (HTN-Japan), and India (HTN-India), and begin to inform clinical trial sites, clinical trial investigators, global regulatory bodies, and customers of these findings and decisions. Medtronic also says it intends to ensure patient access to the SymplicityTM technology at the discretion of their physicians in markets where it is approved. Additionally, Medtronic states that intends to continue the global SYMPLICITY post-market surveillance registry and renal denervation studies on other non-hypertension indications.
On January 21 Covidien announced that it will exit its OneShot™ Rendal Denervation Program. According to its press release, its decision is primarily in response to slower than expected development of the renal denervation market. As a result, Covidien reports that it will not proceed with its RAPID II randomized study and expects to record after-tax charges from $20 to $25 million as a result of exiting its OneShot™ program.