Orchestra BioMed Gets FDA IDE Approval for U.S. Trial of Sirolimus Balloon vs. Paclitaxel Balloon

Orchestra BioMed Holdings, Inc., an innovative biomedical company, has announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to its Investigational Device Exemption (IDE) for a significant clinical trial. This trial will focus on the Virtue® Sirolimus AngioInfusion Balloon™ (Virtue SAB) technology, specifically for the treatment of coronary in-stent restenosis (ISR). The trial, named the Virtue Trial, will be the first of its kind in the U.S., offering a direct comparison between Virtue SAB and the AGENT™ paclitaxel-coated balloon in a randomized, head-to-head evaluation.

Virtue SAB is distinct in the world of drug-eluting balloons because it is not coated but uses a proprietary method to deliver sirolimus, a drug noted for its efficacy in preventing arterial restenosis. This advanced delivery system, SirolimusEFR™, ensures that therapeutic levels of sirolimus are maintained in the tissue over an extended period. The FDA has recognized Virtue SAB as a Breakthrough Device, highlighting its potential in treating coronary ISR, small vessel coronary disease, and peripheral artery disease below-the-knee.

The trial aims to establish the non-inferiority of Virtue SAB compared to the AGENT paclitaxel-coated balloon. The trial will assess outcomes in terms of Target Lesion Failure, which includes cardiac death, nonfatal myocardial infarction in the target vessel, and ischemia-driven target lesion revascularization within 12 months. Approximately 740 patients will be involved in this trial, which will take place across up to 75 centers in the United States. The trial's initiation is anticipated in the latter half of 2025, pending the recent IDE amendment approval.

In previous studies, Virtue SAB has shown promising results, including a remarkably low 12-month target lesion failure rate and minimal late lumen loss over six months. Dr. Dean J. Kereiakes, a leading figure in interventional cardiology, emphasized that Virtue SAB provides a consistent and significant delivery of sirolimus, addressing some of the limitations associated with traditional drug-coated balloons. Dr. Allen Jeremias, another principal investigator, noted the unique mechanism of Virtue SAB, which involves the delivery of a large liquid dose of sirolimus, setting it apart from existing technologies.

David Hochman, Chairman and CEO of Orchestra BioMed, expressed confidence in Virtue SAB's potential to revolutionize the standard of care in treating atherosclerosis. He noted that the trial's head-to-head design against the AGENT paclitaxel-coated balloon underscores their belief in the distinctive advantages of Virtue SAB.

Coronary ISR poses a significant challenge as it involves the re-narrowing of a previously stented artery, leading to increased risk of severe heart conditions. It is estimated that coronary ISR affects a considerable number of patients annually, necessitating effective therapeutic interventions. Virtue SAB’s design aims to meet this need by maintaining the required therapeutic concentration of the drug over critical healing periods, without the necessity of a permanent implant.

Orchestra BioMed is committed to advancing high-impact medical technologies through strategic partnerships, as demonstrated by their collaborations with major medical device companies like Medtronic and Terumo. These partnerships are crucial for the development and commercialization of their groundbreaking products, such as the Virtue SAB and AVIM therapy for hypertension.

With the forthcoming Virtue Trial, Orchestra BioMed is poised to take significant strides in offering advanced solutions for cardiovascular diseases, addressing a high unmet clinical need and potentially transforming patient outcomes.