Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected […]
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Orchestra BioMed wins breakthrough nod for Virtue SEB
Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. The New Hope, Pa.-based […]
Orchestra BioMed receives FDA Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon
Orchestra BioMed recently announced that its Virtue Sirolimus-Eluting Balloon has received Breakthrough Device destination from the FDA. The Breakthrough Designation is granted to medical devices and device-led combination products that can provide a more effective treatment of life-threatening or other debilitating diseases. It allows for medical devices to be expedited in their development, assessment and […]