Transforming Cardiovascular Care: Three of the Latest Innovations

By: Dr. Perez-Villa, Florida-based Senior Engagement Partner for Cleveland Clinic Innovations

Note: This article is reprinted from Cardiac Care: An Update for Physicians from the Heart, Vascular and Thoracic Institute (Spring 2024)

It is vital to keep up with cutting-edge developments in the dynamic field of cardiovascular medicine, and many startups armed with pre-market technologies are ready to transform cardiovascular healthcare. Here, we present three promising technologies that may reshape how we address cardiovascular diseases.

SirPluxTM Duo Drug-Coated Balloon

Advanced NanoTherapies Inc. (ANT) has entered the spotlight with its proprietary nanotechnology-driven technology – SirPlux Duo Drug-Coated Balloon – which utilizes 100% biodegradable nanoparticles for precise drug delivery to the target site. This breakthrough technology extends beyond cardiovascular applications to offer noninvasive solutions for various medical conditions in specialties such as orthopaedics and neurology.

One of the hallmarks of ANT’s nanotechnology is its ability to provide sustained drug release and tissue retention, akin to stent-like patency, effectively thwarting restenosis. This is achieved with lower doses of sirolimus and paclitaxel, which harness their combined antiproliferative power. The SirPlux Duo DCB leaves no permanent implant behind, safeguarding long-term arterial health without the risk of late stent thrombosis and offers potential positive economic implications by reducing treatment costs compared to traditional stent-based interventions. In August 2023, ANT announced a $4M Series A extension from a prominent undisclosed strategic medical device company and the company plans to share angiographic data from its ADVANCE-DCB FIH trial in early 2024.

Cardiac Pulmonary Nerve Stimulation

Cardionomic Inc. has created the Cardiac Pulmonary Nerve Stimulation (CPNS) system that holds promise as a potential game-changer in the treatment of acute decompensated heart failure (ADHF). CPNS is a catheter-based investigational device designed to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery, improving inotropy and lusitropy by increasing systemic perfusion and enhancing decongestion in ADHF. Early research has demonstrated that this system effectively increases cardiac contractility in patients with chronic heart failure while maintaining heart rate stability. Cardionomic Inc. is currently enrolling patients in the United States, the European Union, and Panama for the STOP-ADHF Study, which investigates the safety and performance of the CPNS System in patients hospitalized for ADHF.

Subvalvular Spacer^TM

Mitria Medical’s Subvalvular Spacer is a percutaneously delivered nitinol braid designed to treat mitral regurgitation with a focus on preservation rather than resection. The device is placed by puncturing the mitral valve annulus at the desired implant location, and then is delivered through known transcatheter techniques. This novel device sits at the hinge of the posterior leaflet, with the top (smaller) aspect sitting on the atrial side for anchoring, and the bottom (larger) aspect sitting under the leaflet to provide broad support to the displaced leaflet and associated subvalvular apparatus moving them anteriorly to restore coaptation and reduce mitral regurgitation. Mitria completed the first-in-human cases via a surgical approach, treating two patients and resulting in an acute reduction of mitral regurgitation (2-grade reduction from baseline) while maintaining a normal mean gradient after follow-up at 6 and 12 months.

Dr. Perez-Villa is a Florida-based Senior Engagement Partner for Cleveland Clinic Innovations.