An Unmet Need in Coronary Stenting
Coronary stents have evolved over the last 20-years to become the standard of care for patients undergoing percutaneous coronary intervention (PCI) for the treatment of atherosclerosis. The well-established $5 billion global coronary stent market is expected to grow: in addition to general increases in healthcare spending, the number of stents used per procedure is increasing as more complex lesions are treated through PCI.
However healthcare has changed substantially over the last 10-years. Whereas focus previously centered on attaining the best possible clinical outcomes, today patient satisfaction and cost containment are increasingly important considerations in the treatment of coronary artery disease.
To improve patient experience and resource management in the cath lab, streamlined procedures and shorter times to ambulation with no compromise to care are needed. Adding value, i.e. improving healthcare outcomes per dollar spent, is required of all new technologies. Yet advancements in drug-eluting stents (DES) continue to focus on refining existing platforms to marginally improve stent delivery and develop more biocompatible drug polymers.
Svelte Medical Systems was founded to establish a new paradigm in stenting, one conveying benefits to all constituents of the modern healthcare environment – patients, physicians, providers and payers.
Headquartered in New Providence, New Jersey, Svelte Medical Systems is a privately-held company dedicated to redefining the approach to coronary stenting. Engaged in the design and development of highly deliverable balloon expandable stents since its founding in 2007 by Robert (ScD), David (PhD) and Tim (MD) Fischell, Svelte products must meet three clear objectives:
- Provide exceptional clinical outcomes AND
- Enhance patient comfort AND
- Reduce healthcare system costs
From concept through commercialization, Svelte technologies are purposefully designed to combine state-of-the-art performance with procedural efficiency, yielding highly differentiated products with benefits unlike any other DES.
SLENDER Integrated Delivery System (IDS)
Downsize Catheters, Facilitate Transradial Intervention
The SLENDER IDS drug-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) is the first advance in stent delivery since the rapid-exchange catheter. The world’s lowest profile DES and only DES indicated for use in diagnostic and small catheters (0.047” ID), SLENDER IDS downsizes catheters and is designed to facilitate transradial intervention (TRI), the clinical and economic benefits of which are well known.
Incorporating specialized ASAHI guide wire tip technology and proprietary balloon designs to enhance direct stenting, SLENDER IDS navigates coronary arteries like a guide wire, eliminating the need for additional guide wires and balloons in most cases. This ‘all-in-one’ approach to PCI simplifies procedures and allows more efficient utilization of cath lab resources, offering significant cost savings to healthcare providers.
DIRECT Rapid Exchange System (RX)
Enhance Direct Stenting Across More Patient Subsets
The DIRECT RX rapid-exchange DES system utilizes proprietary balloon designs to enhance direct stenting and high-pressure post-dilatation(s) in the event a conventional wire-based approach to coronary stenting is preferred. The ability to direct stent more lesions with confidence reduces procedure time and adjunctive product use while optimizing patient outcomes.
DISCREET Drug Coating
Designed for Direct Stenting and to Promote Healing
Svelte DISCREET drug coating represents an entirely new class of bioresorbable drug coating composed of naturally-occurring amino acids and the well-studied antiproliferative compound sirolimus. With the toughness and mechanical integrity necessary for direct stenting, DISCREET promotes healing and delivers safe and exceptional long-term clinical outcomes.
In search of a better drug delivery system, Svelte partnered with DSM Biomedical, a global leader in biomaterials science and regenerative medicine. Using DSM’s proprietary polyesteramide (PEA) bioresorbable coating, a new class of drug carrier technology was developed. The result is DISCREET drug coating, which in clinical studies has delivered 0% death or stent thrombosis and exceptionally low TLR with more than 3 years of follow-up.
Specialized Stent Design
Low Profile, High Performance
Unique geometry with variable length struts cut from fine grain cobalt chromium allows the Svelte stent to attain profiles as low as HALF the crimped area of conventional stents* without compromise to strut thickness, radial strength or recoil. Flexible, conformable and strong, the ultra-low profile stent platform used with SLENDER IDS and DIRECT RX is highly deliverable and designed to optimize vessel scaffolding with direct stenting.
Innovative Balloon Technology
Enhance Direct Stenting Across More Patient Subsets
SLENDER IDS and DIRECT RX platforms incorporate unique and proprietary balloon technologies specifically designed to address these concerns. To minimize unwanted stent contact during direct stenting, low-complant balloon materials and proprietary balloon treatment methods were developed. Designed to enable safe stent delivery and multiple, high-pressure balloon inflations, if necessary, to optimize outcomes with direct stenting across a wide range of lesions, Svelte balloon technology optimizes clinical outcomes while reducing the need for additional NC post-dilatation balloons and potential for geographic miss.
With the shift in today’s healthcare environment toward cost containment, adding value, i.e. improving healthcare outcomes per dollar spent, is a requirement of new technologies. By combining a guide wire, specialized balloon technology and a highly flexible stent into a single ‘all-in-one’ system, Svelte technologies streamline stenting procedures and achieve procedural efficiencies unlike any other DES, resulting in material cost savings between $119-$5921-3 per case.
Svelte technologies downsize catheters, facilitate TRI, reduce the need for adjunctive materials and shorten procedure times while delivering safe long-term results: ZERO death or stent thrombosis through 4 years and exceptionally low TLR rates through 2 years are reported in Svelte clinical studies.