ReCor Medical has received CE-mark for the latest generation of its ultrasound-based Renal Denervation(RDN) system for blood pressure reduction in treatment resistant patients. The company is pointing to major advances in its Paradise System™, no doubt hoping to exploit the current turmoil and confirming its commitment to stay in the game.
A couple of weeks ago the medtech industry was reeling at the news that Medtronic’s Symplicity HTN-3 study had failed to meet its efficacy endpoints in the treatment of resistant hypertension (HTN). What followed was a lot of companies palpably easing off the accelerator while they took stock, while notably Covidien announced its decision to pull the plug on its efforts.
Some companies hinted that they thought the reason for the disappointing results might lie to some extent in the rather first generation design that is the single electrode Symplicity system. At the time we predicted we might see a little more of this behaviour, as companies seek to convince us that their own technology differs to that of Medtronic’s. Of the other players of note, ReCor Medical has perhaps the best claim to be able to “Vive la Difference”, its system using ultrasound energy to get the job done, as compared with the RF energy delivered by the likes of Symplicity. ReCor’s Paradise device is the only CE-Marked RDN system that uses radial ultrasound as its energy source, which it combines with water-based convective cooling, allowing for the potential for faster procedures, more thorough renal denervation, and improved vessel safety.
“The initial procedures with the new Paradise System highlighted the new generator’s ability to automatically customize energy delivery based on the patient’s artery size while maintaining a consistent level of cooling protection,” said Professor Thomas Zeller, MD and Dr. Elias Noory, MD. following their use of the system at the Universitats–Herzzentrum, Bad Krozingen, Germany. “Our first patient treated with the new Paradise System was a non-responder of two different radio frequency-based procedures. We are optimistic that the circumferential energy delivery of the Paradise ultrasound system will provide a more reliable treatment.”
The company has also announced the first use of its new catheter line, called Radiance, which is 5Fr and rapid-exchange compatible, and thus sized to be introduced via the radial artery – as opposed to the femoral artery.
“Last Friday’s procedures using the new Radiance catheter with access via the radial artery marks a significant new approach to making the RDN procedure quicker, safer, and potentially more cost-effective for hospitals and patients,” remarked Drs. Nicolas Van Mieghem and Joost Daemen from Erasmus Medical Center in Rotterdam, the Netherlands, who performed the first radial procedure. “This system’s radial artery access and 10 second ablation time should allow us to treat a patient in a minimally invasive way within 30 minutes, and then let that patient go home the same day.”
“Following the recent publication of negative results from one of the RDN clinical trials, some competitors have announced that they are either delaying, reducing or abandoning efforts to commercialize their RF-based RDN products. Having reviewed our own clinical results and spoken to clinicians who have collectively treated hundreds of patients with resistant hypertension using different RDN systems, ReCor is convinced that our product is well-differentiated from these RF-based approaches,” said ReCor Medical President & CEO, Andrew M. Weiss. “We remain convinced that RDN has the potential to become a key component of HTN therapy, and believe that our Paradise System provides the safe, reliable and complete denervation needed to become the category leader in this field.”
Source: ReCor Medical, Inc., PR Newswire