ReCor Medical, a healthcare products startup based in California, announced that it has launched a post-market study of its next-generation Paradise system. The Paradise system is a renal denervation device that uses ultrasound to treat drug-resistant hypertension.
According to a press release by the company, ReCor Medical has already enrolled qualified patients at a facility in the Netherlands. Patients participating in the study will be treated with the Paradise device. As of now. Paradise is the only ultrasound renal denervation system available in Europe.
The new study follows CE Mark approval in the European Union for the Paradise system. Approval of the Paradise system puts ReCor Medical in the same league as industry giants like St. Jude Medical and Medtronic, both of which have CE Mark products for renal denervation.
Renal denervation is a minimally-invasive therapy that uses ultrasound energy to modulate renal nerves near a patient’s kidney. By disrupting these nerves, the Paradise system can lower blood pressure. Untreated high blood pressure can increase an individual’s risk of stroke, kidney failure or heart attack.
Mano Iyer is the CEO of ReCor Medical. In prepared remarks, he said, "Our novel ultrasound approach is designed to be more effective than radiofrequency, which is restricted in its depth of penetration to just a few millimeters because of inconsistent arterial wall contact, in addition to RF's inability to heat circumferentially in any given location.”