Rapid Renal Sympathetic Denervation for Resistant Hypertension

Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.

Inclusion criteria

• Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
• Age 18-85 years.
• Able to provide informed consent and comply with follow-up visits.

Exclusion criteria

• Diameter of left or right renal artery less than 4 mm or greater than 7mm.
• Length of target segment of left or right renal artery less than 20mm.
• Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
• End-stage renal disease requiring dialysis or renal transplant.
• estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2.
• Type 1 diabetes mellitus.
• Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
• Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
• Bleeding disorder or refusing blood transfusions.
• Pregnancy or breast feeding.
• Peripheral vascular disease precluding catheter insertion.
• Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
• Current enrollment in another investigational drug or device Study.