Orchestra BioMed Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue Sirolimus AngioInfusion Balloon in Patients with Coronary In-Stent Restenosis - Seite 2

The Virtue SAB IDE approval was supported by encouraging three-year follow-up results from the pilot SABRE Study, a European multi-center, prospective, independent core lab-adjudicated clinical trial in coronary ISR patients. The Virtue ISR-US pivotal study is a randomized, prospective, double-blind, multi-center, controlled study of Virtue SAB vs. Plain Old Balloon Angioplasty (“POBA”) in the treatment of single-layer coronary ISR. The study’s primary efficacy and safety endpoint is target lesion failure (“TLF”) at 12 months. The study will randomize approximately 300 participants 2:1 to Virtue SAB or POBA. In parallel to the randomized arm of the study, Orchestra BioMed plans to enroll a non-randomized arm consisting of approximately 100 participants with double-layer coronary ISR for treatment with Virtue SAB. 

Dean J. Kereiakes, M.D., FACC, MSCAI, President of The Christ Hospital Heart & Vascular Institute, Medical Director of The Christ Hospital Research Institute, Professor of Clinical Medicine at The Ohio State University, and the Principal Investigator for the Virtue ISR-US study commented, “Virtue SAB’s differentiated design, as well as the encouraging three-year clinical results from the pilot SABRE study make it a potentially compelling treatment option for coronary artery disease indications. The IDE approval of this study represents a crucial step toward generating important data for establishing Virtue SAB’s safety and efficacy and advancing this unique, sirolimus-based leave-nothing-behind therapy to coronary ISR patients.”

The Company is permitted to begin enrollment upon completion of standard clinical trial initiation activities including clinical center Institutional Review Board approvals. The conditional approval also requires the Company to submit additional information to the FDA.

About Coronary In-Stent Restenosis (ISR)
Coronary ISR is a serious complication of coronary stenting which can increase the risk of life-threatening heart problems. It is characterized by a re-narrowing of a coronary artery segment that was previously treated with a stent. According to the National Cardiovascular Data Registry, coronary ISR occurs in up to 10% of stented patients during the first year and continues at a rate of up to 3% per year thereafter, resulting in an estimated over 325,000 coronary ISR lesions annually worldwide that may require treatment. The only device treatments currently approved by the FDA for use in coronary ISR lesions are balloon angioplasty and intravascular radiation therapy known as brachytherapy. Traditional balloon angioplasty has high retreatment rates and brachytherapy is considered a last resort treatment due to radiation burden, expense, limited availability, and long-term requirement for dual antiplatelet therapy. If left untreated, coronary ISR may lead to stable angina, unstable angina, acute coronary syndrome, acute myocardial infarction, or death.