Outcomes

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Procedural Efficiency

Svelte technologies enhance procedural efficiency by reducing the steps, materials and time necessary to perform coronary stenting.

In a world where product safety and efficacy is well established, new stent technologies must be developed to address efficiency and cost management.  Svelte technologies, by design, optimize the use of preciously scarce resources – time and people – to address the needs of the modern healthcare environment: provide exceptional clinical outcomes and enhance procedural efficiency.

SLENDER IDS is composed of the highest quality designs and materials to simplify procedures, including:

  • ASAHI guide wire technology
  • Low-compliant balloon material
  • A flexible and conformable thin-strut stent
  • DISCREET: a new class of bioresorbable drug coating

DIRECT RX combines the same low-compliant balloon, stent and drug coating technology with a rapid-exchange chassis with a manicured tip designed for direct stenting.

These technologies provide exceptional clinical outcomes, enhance patient comfort and create procedural efficiencies unlike any other DES.

Facilitate TRI and Direct Stenting

In multiple clinical studies, the ultra-low profile and reinforced proximal shaft of SLENDER IDS has been shown to facilitate TRI and direct stenting, even in complex anatomy. This reduces the risk of bleeding complications, use of additional PTCA balloons, contrast administration and procedure time.

Despite many investigators being first-time users of the IDS in the DIRECT I and II clinical studies:

  • 98% of cases were free of device failure
  • 96% of lesions were direct stented successfully
  • 74% of patients were treated via transradial approach

Technology designed to facilitate TRI and direct stenting across more subsets benefits patients, physicians, providers and payers.

Streamline Procedures

Conventional stenting procedures can be time consuming and costly.  Conventional rapid-exchange (RX) platforms require multiple steps and product exchanges when performing PCI.  Use of SLENDER IDS offers the possibility to enhance patient clinical benefit and comfort while reducing procedural time and cost.

slender ids procedural step reduction

By integrating a stent with a fixed-wire platform, exceptionally low profiles are achieved, deliverability is enhanced and the number of steps and time required to complete PCI are reduced.

In the DIRECT II randomized, controlled study, significant reductions in procedure and device time were achieved, while trends toward reduction in radiation exposure and contrast use were observed versus a conventional rapid-exchange DES control arm.

direct study procedural efficiencies

Studies over the last 5 years utilizing the Svelte bare metal stent demonstrate consistent procedural efficiency outcomes along with added cost benefits:

  • 10-23% reduced contrast use and radiation exposure1,2
  • 20-55% reduced device and procedure time1,3
  • $119 – $592 reduced material costs2,3,4,5

And as the only DES indicated for use with diagnostic and smaller catheters (0.047″ ID), SLENDER IDS offers operators the unique opportunity to perfrom diagnostic angiography and seamlessly continue onto a therapeutic approach.

Smaller access site size faciliatates TRI in larger subsets of patients, reducing risk of bleeding complications, enhancing patient comfort and better enabling same-day discharge after PCI, if desired.

SLENDER IDS also offers the possibility of simplifying cases, even in complex anatomy.

Whether simple, straightforward PCI or multiple lesion vessels, Svelte technologies streamline procedures and reduce material use compared with current standard of care.

LESS IS MORE.  Less trauma, materials, time and cost.   More patient comfort, physician satisfaction and procedural efficiency.

Downsize Catheters.  Optimize Outcomes.  Enhance Efficiency.

References:

1 – Diletti et al. EuroIntervention 2013;9:125-134.

2 – Khattab et al. Cath and Cardiovasc Interv. 82:E403-E410 (2013).

3 – S. Verheye et al.  DIRECT II presentation at EuroPCR 2015.

4 – Khattab et al.  Cath and Cardiovasc Interv. 85:E23-E31 (2015).

5 – Devito et al. Jnl Invasive Cardiol. Epub ahead of print August 25, 2015.

 

   DIRECT I clinical study.

 DIRECT II clinical study.

 

CAUTION: The law restricts SLENDER IDS to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. SLENDER IDS is CE approved. DIRECT RX is an investigational device not approved for commercial use. SLENDER IDS and DIRECT RX are not available for sale in the US.