NEW HOPE, PA — Two groundbreaking presentations were announced at the recent Cardiovascular Research Technologies (CRT) 2024 Meeting by Orchestra BioMed Holdings Inc., a headline-grabbing revelation that left the industry buzzing.
Among these was new preclinical data on the Virtue® Sirolimus AngioInfusion Balloon (SAB), an avant-garde drug-eluting balloon angioplasty system. This system aims to deliver SirolimusEFR™, a proprietary, extended-release formulation of sirolimus, to the vessel wall during balloon angioplasty without requiring a coating on the balloon surface.
Meanwhile, the second presentation focused on the exciting clinical data around atrioventricular interval modulation (AVIM) therapy or BackBeat CNT. This investigational therapy is designed to immediately, significantly, and persistently lower blood pressure and is delivered via standard dual-chamber pacemakers.
Dr. Dean Kereiakes, a luminary in the field, detailed the innovative attributes of the Virtue SAB. Developed to treat coronary in-stent restenosis (ISR), the Virtue SAB offers several stellar advantages such as no drug loss in-transit to a target arterial lesion. It also promises focal uptake and extended release of sirolimus at tissue concentrations beyond the 1 ng/mg tissue concentration acknowledged as necessary for controlling cellular proliferation during the crucial healing period.
The benefits of sirolimus, a tried-and-true therapeutic for drug-eluting stents, can now be delivered without the potential risks associated with a permanent metal implant or a balloon surface coating, explained Dr. Kereiakes.
The US Food and Drug Administration has given a conditional nod to Orchestra BioMed to commence the Virtue ISR-US pivotal study. This study will evaluate the efficacy and safety of Virtue SAB for patients with coronary ISR.
On the other side of the spectrum, the BackBeat global pivotal study was presented by Dr. Dan Burkhoff. He provided a detailed overview of the AVIM therapy program and shared impressive results showing sustained reductions in 24-hour ambulatory systolic blood pressure over a mean of 3.6 years from treatment activation in AVIM-treated patients. The therapy also demonstrated promising hemodynamic effects.
The AVIM therapy’s mechanism in blood pressure reduction continues to instill confidence in its potential benefits for hypertensive patients within the pacemaker population, Dr. Burkhoff remarked.
These riveting presentations, with their deeply promising clinical data, hold hopeful prospects for the future of cardiovascular therapy. With instruments like Virtue SAB and AVIM therapy on the horizon, Orchestra BioMed continues to resound with innovation and progress, striking a chord in the hearts of industry watchers.
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