FDA has granted a breakthrough device designation for Orchestra BioMed's Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease.
The designation comes just a few months after the New Hope, PA-based announced its partnership with Terumo. The agreement included a $30 million up-front payment to Orchestra plus an equity commitment of $5 million.
Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. Breakthrough device designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. The pathway is intended to expedite the review process.
“Virtue SEB’s unique design enables delivery of sustained-release sirolimus during angioplasty without the need for coating or permanent implant. This highly differentiated design makes this product the ideal candidate for breakthrough device designation in BTK peripheral artery disease,” said James Zidar, MD, a clinical professor of medicine at UNC Health Systems, and physician-in-chief at Heart & Vascular Corporate. “Currently, there is a significant unmet need in the BTK stenosis treatment landscape. The presence of underlying comorbidities renders many patients unsuitable for bypass surgery. Angioplasty with plain balloons, which has been the default endovascular therapy for years, has a low success rate. Adding a proven anti-restenotic agent like sirolimus has the potential to enhance this treatment approach and drive better patient outcomes.”
Darren Sherman, president, COO, and a co-founder of Orchestra BioMed, said the breakthrough device designation will be critical as the company continues to work with Terumo to accelerate the Virtue SEB's global clinical and regulatory program in both coronary and peripheral indications.
"In BTK disease, treatment with Virtue SEB has the potential to improve long-term outcomes and reduce periprocedural complications, which can extend hospital stay and increase [the] cost of treatment," Sherman said.
FDA Rejected BD's Lutonix for the Same Indication
Orchestra BioMed's breakthrough device designation comes at a time when drug-coated/eluting balloons and stents have been closely scrutinized. The big difference, however, is in the drug at play.
Fortunately for Orchestra and Terumo, the concern has centered around paclitaxel devices rather than sirolimus devices. Becton, Dickinson and Company (BD) wasn't so lucky.
Last month FDA rejected BD's Lutonix paclitaxel-coated balloon for BTK peripheral artery disease. BD inherited the device through its $24-billion acquisition of C.R. Bard, a deal that closed at the tail end of 2017. FDA originally approved the Lutonix DCB in October 2014 for patients with above-the-knee peripheral artery disease (the first FDA approval in the DCB category), and in 2017 the agency approved the balloon for end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae.
BD CEO Vince Forlenza said the company would continue to review collaboratively and align with FDA on the path forward regarding the submission, including the need to potentially provide additional data. The company had been expecting the submission to be approved in 2019, but that is no longer the case.