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

2. Mark A. Turco, MD, FACC

3. The Covidien OneShot™ Irrigated RF Balloon System For Renal Denervation

4. 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

5. 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.  

6. OneShot Generator 6

7. Fluoroscopy Images During Renal Denervation

8. Challenging anatomy

10. 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

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

12. 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

13. 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.

14. 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

15. 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 balloon based platform with continuous irrigation. 21