Two new denervation systems were launched at EuroPCR (Paris, 15–18 May 2012). Covidien unveiled its OneShot system and St Jude Medical announced the launch of the EnligHTN system. Both systems are designed to treat patients with hypertension who are not responsive to traditional medical therapy.
The OneShot system is an irrigated, radiofrequency-based balloon catheter used to ablate the renal sympathetic nerves located in the outer wall of the renal arteries. The OneShot technology received CE mark clearance in February 2012.
“For the large subsets of patients who have refractory hypertension and are unresponsive to traditional pharmacologic agents, the field of catheter-based renal denervation holds enormous promise,” said Mark A Turco, chief medical officer, Vascular Therapies, Covidien. “We believe that the OneShot system will provide advantages over existing devices and strengthens Covidien’s leadership in delivering best-in-class vascular solutions.”
Stacy Enxing Seng, president of Vascular Therapies, Covidien,told Cardiovascular News that the device is unique for its concept and design. Its spiral configuration of electrodes, she said, allows a single application of radiofrequency inside the artery, and the irrigated catheter cools the arterial surface with a saline solution. Seng said that Covidien is working on a lower-profile catheter (7F), and added that the system will start being commercialised in the end of 2012.
The OneShot system was featured in live cases at the Covidien-sponsored “Tools & Techniques Interventions” presentation and panel session for hypertension and renal denervation at EuroPCR. Dierk Scheinert performed two cases at Park Hospital in Leipzig, Germany, that were transmitted live at the congress. In addition, John Ormiston, medical director for Mercy Angiography and president of the Asia-Pacific Society of Interventional Cardiology in New Zealand, presented first-in-human results of cases performed with the OneShot system in New Zealand.
Covidien also announced that the first patient in its post-CE mark clinical trial, RAPID (Rapid renal sympathetic denervation for resistant hypertension using the OneShot Ablation System), studying the OneShot system, was enrolled at Middleheim Hospital in Antwerp, Belgium, by Stefan Verheye. This trial will enrol subjects throughout Europe and at a site in New Zealand.
Also at EuroPCR,St Jude announced CE mark approval and launch of its EnligHTN renal denervation system.
“In my experience, the EnligHTN renal denervation system has been successful in reducing blood pressure in patients with resistant hypertension,” said Stephen Worthley, the EnligHTN I trial’s primary investigator from Royal Adelaide Hospital in Australia. “The multi-electrode renal denervation system provides an efficient and effective alternative treatment for patients with resistant hypertension, and has the possibility to change the way that hypertension is treated.”
The EnligHTN system is the industry’s first multi-electrode ablation technology for renal denervation. With a basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals. St Jude stated that, compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies. Additionally, the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (X-ray) exposure.
Preliminary data presented at EuroPCR demonstrated that, on average, patients with resistant hypertension experience a systolic blood pressure reduction of 28 points 30 days after treatment with EnligHTN. Patients who were enrolled in the trial had an average of 176/96mmHg baseline blood pressure despite being on multiple medications to help control blood pressure. The results after 30 days demonstrated an average blood pressure of 148/87mmHg, a 28 point reduction in systolic pressure, and a reduction in systolic blood pressure to below 140 mmHg in 41% of patients.