Covidien to unveil new OneShot renal denervation system at EuroPCR congress

May 8 2012

Covidien (NYSE: COV), a leading global provider of healthcare products, will unveil its new OneShot™ renal denervation system at the EuroPCR congress in Paris, France, on May 16, 2012. Adding to the Company's broad and growing vascular therapies portfolio, the OneShot system is designed to treat patients with hypertension who are not responsive to traditional medical therapy.

“We believe that the OneShot system will provide advantages over existing devices and strengthens Covidien's leadership in delivering best-in-class vascular solutions.”

Millions of people worldwide are impacted from complications of prolonged, uncontrolled high blood pressure. The OneShot system is an irrigated, radiofrequency (RF) 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, MD, 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."

The OneShot system will be featured in "live" cases at the Covidien-sponsored "Tools & Techniques (TNT) Interventions" presentation and panel session for hypertension and renal denervation at the EuroPCR congress. The session will be held on Wednesday, May 16, 2012, from 16:50 -18:50 in the Maillot Room at the Palais des Congrès de Paris.

Professor Dirk Scheinert will perform two cases at Park Hospital in Leipzig, Germany, that will be transmitted live at the Congress. In addition, John Ormiston, MD, Medical Director for Mercy Angiography and President of the Asia-Pacific Society of Interventional Cardiology in New Zealand, will present first-in-human results of cases performed with the OneShot system in New Zealand. The OneShot system and Covidien's other endovascular solutions will be on display at Booth F22 at the EuroPCR meeting.

Additional faculty in the TNT session is a distinguished group of speakers including:

• Professor Karl-Heinz Kuck, MD, F.A.C.C. - Director, Cardiology Department
  Allgemeines Krankenhaus St. Georg - Hamburg, Germany

• Dr. Stephen R. Ramee, FACC, FSCAI
  Ochsner Medical Center - New Orleans, Louisiana

• Dr. John Ormiston, MBChB, FRACP - Medical Director
  Mercy Hospital Angiography Unit - Auckland, New Zealand

• Professor Marc Sapoval, MD, PhD - Department Head
  Cardiovascular/Interventional Radiology - Hospital Popidou University - Paris, France

• Dr. Renu Virmani - Medical Director
  CVPath Institute - Gaithersburg, Maryland

In support of the Company's dedication to evidence-based medicine, Covidien also announces 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, will be enrolled this week at Middleheim Hospital in Antwerp, Belgium, by Professor Stefan Verheye. This trial will enroll subjects throughout Europe and at a site in New Zealand.

Covidien is a recognized leader in RF ablation technology with numerous products in both its vascular and surgical portfolios including: ClosureFast™ catheter for the treatment of chronic venous insufficiency, the Cool-tip™ RF ablation system for thermal ablation of non-resectable liver tumors and osteoid osteomas, the HALO ablation system used to treat Barrett's esophagus in conjunction with endoscopy by removing precancerous tissue from the gastrointestinal tract, and LigaSure™ vessel sealing for permanent vessel occlusion.

These product lines have helped millions of patients worldwide. Covidien will leverage its expertise in RF technology while providing patients with new therapeutic options for poorly controlled hypertension.

Covidien is committed to advancing the treatment of vascular disease worldwide and will feature products at EuroPCR that represent a comprehensive portfolio of technology-driven solutions. Through a disciplined approach that leverages clinical evidence, world-class education programs and customer collaboration, Covidien is focused on revitalizing and preserving life for patients with vascular disease.

Source Covidien