OneShot™ Renal Denervation System Mark A. Turco, MD, FACC Chief Medical Officer Covidien Vascular Therapies Tuesday February 26, 2013

Mark A. Turco, MD, FACC

The Covidien OneShot™ Irrigated RF Balloon System For Renal Denervation

OneShot™ Renal Denervation System Single-treatment RF ablation per artery reduces procedure time (2 min. total per artery) Spiral electrode design offers standardized and reproducible ablation pattern Integrated irrigation cools the non-treated region of the artery Low pressure, balloon-based system delivered over a standard 0.014" wire

The OneShot System marked by two radiopaque markers for visualization under fluoroscopy 8 evenly-spaced irrigation holes around balloon on either sides of electrode Available in 5mm, 6mm, and 7mm balloon diameters Delivered over a standard .014” guidewire 20mm Low pressure irrigation runs continuously during balloon inflation, providing cooling of the non-treated region of the artery during therapy. The OneShot Renal Denervation System is CE Mark approved.  The OneShot System is not approved for sale in the United States.  

OneShot Generator 6

Fluoroscopy Images During Renal Denervation

Challenging anatomy

RAPID Trial (RApid Renal SymPathetIc Denervation) for chronic resistant hypertension using OneShot™ Objectives: Confirm safety and evaluate effectiveness of OneShotTM for the treatment of chronic resistant hypertension Design: Prospective, single arm, multi-center clinical study Patient Population: Patients diagnosed with documented chronic treatment‐resistant, but stable hypertension and who are treated at or referred to the participating study center are eligible for study screening. Chronic treatment-resistant is defined as systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti‐hypertensive medications that includes a diuretic Study Size: Enrolled 50 patients with enrollment completed Feb 2013

Non Responders Symplicity HTN II investigaors; The Lancet 2010; 376:1903

Factors Which Impact on Lesion Size Controllable and Known Factors Temperature- / Power-setting Duration of energy application Electrode tip size Irrigation Not controllable / Unknown factors Cooling from cavitary blood flow Electrode-tissue contact Electrode-tissue pressure Electrode-tissue orientation

Energy → Tissue heating RF Ablation – Lesion Formation: Lessons from the EP Docs Energy → Tissue heating therefore ↑ Lesion size ↑ Energy → ↑ Tip temperature ↑ Catheter-tissue interface temperature For Safety: Catheter tip temp should remain  65C to avoid thrombus and charring.

Irrigated RF Treatment - Rationale Irrigated Catheter Active cooling of electrode tip by irrigation fluid Allows use of higher power settings without reaching critically high tip temperatures High power produces larger and bigger lesions Less charring Less thrombus

Summary Aims for new devices for renal denervation: shorter treatment times with a more effective and safer ablation as well as minimizing non responders. The OneShot catheter provides a single ablation over a non compliant 0.014 balloon based platform with continuous irrigation. 21