DYAD MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Software for OCT Analysis of Vascular Stents PI Ronny Shalev PhD Dyad Medical Summary Dyad Medical Inc will create intravascular OCT IVOCT software for clinical live time determination of stent apposition OCTivat live the live time OCT image visualization and analysis tool and for offline analysis of stent implantation OCTivat stent Every year s of thousands of patients in the US are treated with intra vascular stents creating an opportunity for both solutions Although advancements such as drug eluting metal stents hinder restenosis there remains significant room for improvement Stent design parameters include drug material bioresorbable vs metal polymer composition coatings to stimulate cell coverage etc To opti mize designs sensitive in vivo assessments are needed for preclinical and clinical evaluations Intravascular OCT IVOCT is the lone imaging modality with the resolution and contrast to meet this challenge The Core Lab at CWRU is the premiere site in the world for manual analysis of IVOCT image data A cardiologist analyst takes hrs to analyze manually a single stent and despite training and quality assurance measures inter analyst variability can limit the power to determine changes between stent designs Building upon work at CWRU we will develop advanced highly automated software to greatly speed analysis improve reproducibil ity increase accuracy and harmonize analysis Software will reduce costs by decreasing manual labor and with improved reproducibility possibly enable the use of historical data eliminating cost of a control arm Re garding live time analysis rather than manually reviewing andgt images in a pullback with fast software it will be possible to present the number and location of malapposed struts in D providing instant feedback to phy sicians on the need for additional dilatation with a larger balloon or higher pressure In addition we will auto matically determine stent and vessel area along the length of the pullback allowing us to compute stent ex pansion and eccentricity quantitative measures related to successful stent deployment the most important de terminant of outcome IVOCT could also play a role at patient follow up If a stent is well covered then long term anti platelet therapy might be unnecessary minimizing bleeding risk If a stent has many uncovered struts a therapeutic might prevent stent thrombosis or stimulate healing Project Narrative We will develop methods for improved in vivo assessment of intravascular stents the treatment of choice for s of thousands of patients suffering from ischemic heart disease in the US every year Our methods will enable optimization of stent technologies and improved deployment for improved treatment of vascular dis ease