FDA Granted SirPlux Duo Drug-Coated Balloon Breakthrough Designation

On September 19, 2022, the FDA granted Advanced NanoTherapies a Breakthrough Device Designation (BDD) for its SirPlux Duo Drug-Coated Balloon (DCB) to treat coronary artery disease. Based on the press release, the device was approved for coronary in-stent restenosis and peripheral below-the-knee lesions previously.

This new designation approves the device for use to treat coronary artery disease in vessels smaller than 3 mm.

The device uses two medications: sirolimus and paclitaxel. According to the press release, this device is a “front-line therapy engineered to provide stent-like patency and restenosis prevention while leaving no implant behind. SirPlux Duo DCB delivers low-dose, long-term release of both compounds to inhibit cell growth, resulting in maximum potency exceeding any other DCB or drug-eluting stent.”

Compared to traditional devices, this technology has multiple benefits. Beyond not leaving behind an implant, DCB technology can reduce the risk of acute thrombosis, improve vascular remodeling, and shorten dual antiplatelet therapy.

"Despite decades of advances in drug-eluting stents, treating small coronary vessels continues to be challenging due to the unacceptable incidence of restenosis and target lesion failure," commented Dr. Rishi Puri MD, PhD, Coronary and Structural Heart Interventional Cardiologist in the Tomsich Family Department of Cardiovascular Medicine at Cleveland Clinic and Co-Principal Investigator of the Company's ADVANCE-DCB clinical trial, in the press release. "Advanced NanoTherapies is championing a novel stent-free option to address this clinical gap. I look forward to seeing how this technology can advance the field of coronary interventions by improving long-term clinical outcomes and preventing the need for repeat revascularizations."

In addition to the multiple medical benefits listed in the press release, the company’s website also notes that it is a less expensive treatment route. They share that the device itself and the procedure overall should be more cost-effective. In addition to upfront costs, the company claims that, due to its increased efficacy, there will be significantly less need for re-intervention, reducing the cost of reintervention therapies.

As the device is made accessible for treating these diseases, providers may consider weighing the benefits of the device with unknown risks.