Svelte Medical Systems

Svelte Medical Systems, founded in 2007 by the accomplished Fischell family—David, Robert, and Tim—is a privately-held company focused on developing advanced coronary stent systems. The company operates within the health care equipment industry, specifically targeting the challenges of coronary artery disease. Its headquarters are in New Providence, New Jersey.

The business is centered on creating and commercializing highly deliverable balloon-expandable stents. Svelte Medical Systems serves interventional cardiologists and aims to improve patient outcomes while reducing procedural complexity and costs. The company generates revenue through the sale of its specialized medical devices to healthcare providers and hospitals.

A key offering is the SLENDER Integrated Delivery System (IDS), an 'all-in-one' system that combines a guidewire, balloon, and stent. This design streamlines percutaneous coronary interventions (PCI) by eliminating several steps, which can reduce procedure time, radiation exposure, and cost. Another primary product is the DIRECT RX, a rapid-exchange drug-eluting stent (DES) system. Both systems utilize a bioresorbable drug coating which demonstrated a very low 1.5% clinically-driven target lesion revascularization (TLR) at one year in clinical studies. These products are specifically designed to facilitate transradial intervention (TRI), a procedure where access is gained through the wrist, enhancing patient comfort and reducing complications. A significant milestone was achieved in December 2021, when the company received U.S. Food and Drug Administration (FDA) approval to commercialize both the SLENDER IDS and DIRECT RX systems in the United States.

Keywords: coronary artery disease, drug-eluting stent, balloon expandable stents, interventional cardiology, medical devices, percutaneous coronary intervention, transradial intervention, SLENDER IDS, DIRECT RX, bioresorbable coating, cardiovascular devices, stent delivery system, angioplasty, healthcare equipment, Fischell, minimally invasive, cardiac care, FDA approval, medical technology innovation