Symple Surgical Inc — Department of Health and Human Services SBIR Phase I: R

Description

PROJECT SUMMARY Increased renal sympathetic activity is a causal pathogenetic mechanism of both cardiovascular hypertension and progressive loss of renal function in patients with chronic kidney diseaseCKDIn millions of patients with resistant hypertensiondependable thermal disruption of targeted renal sympathetic nerves can reduce blood pressure and ultimately prevent heart diseasestroke and kidney failureThis has generated much excitement about the field of renal sympathetic denervationRSDNCurrently available ablation catheters are plagued by inconsistent heating and absence of thermal feedback from the targeted treatment volumesignificantly reducing RSDN benefitsOvercoming limitations of current RSDN device is thus an urgent clinical needWe propose to integrate reliable heating mechanism with real time accurate thermal feedback into an innovative low cost ablation deviceThe proposed InSiteRSDN catheter utilizes a dual purpose microwave antenna which provides two unique advantagesidependable ablation zone by angularly uniform and artery sparing targeted heatingiireal time dosimetry and guidance by passively collecting thermal radiation from multiple sensing volumes with an ultrasensitive radiometerThe immediate goal is to implement accurate temperature feedback in the microwave ablation catheter and test the complete system in realistic phantom and ex vivo modelsThe long term objective is to dramatically improve reliability and accuracy of renal denervation by providing clinicians with precise nerve targeting and real time thermal dosimetryThe rationale for our combined approach is that previous developments at Symple Surgical and Duke University already established suitable technology for both targeted heating and multi frequency radiometryOur underlying hypothesis is that by combining the best microwave technologies to ablate and monitor temperaturewe improve treatment qualityBetter therapy will ultimately improve clinical outcomes while maintaining safety profileFor Phase Ithese are the specific aimsIntegrate multiband radiometric sensing into a micro ablation catheter for continuous control during percutaneous RSDNTest the ability to accurately feedback microwave heatingin realistic phantom and ex vivo renal tissue modelsBy end of Phase Ithe device will be ready for subsequent animal and human studies in Phase II to correlate ablation zones with effective nerve deactivation areasSpecific milestones to prove Phase I success areOptimized integration of high sensitivity multiband radiometry in an intravascular microwave ablation catheterAlgorithm to reconstruct volumetric tissue temperature across the heated zone at multiple distances from the renal artery wallSoftware that implements real time ablation feedback and displays precise temperature profilesPreparation of all hardwaresoftwareproceduresand approvals for clinical investigation in Phase IIThe overall expected outcome is a novel RSDN catheter with angularly symmetric ablation and realtime thermal dosimetryWe anticipate that catheterization labs will adopt InSiteablation catheter to accurately control size and quality of RSDNthereby reducing death from cardiovascular disease and chronic kidney failure PUBLIC HEALTH AND RELEVANCE STATEMENT We propose to combine multi frequency radiometry with microwave heating to improve significantly renal sympathetic denervationRDNby thermal ablationThe novel technology uses a single disposable microcatheter to thermally deactivate overactive sympathetic nerves that are a pathogenesis for resistant hypertensiona main cause of heart diseasestrokeand progressive loss of renal function in patients with chronic kidney diseaseThe novelaffordableand accurate therapeutic tool will ultimately lower the cost of healthcarereduce outcome disparity in hypertensive patients and benefit millions of people in US and worldwide