Technology

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SLENDER IDS Integrated Delivery System

The first advance in stent delivery in more than 20 years, SLENDER IDS downsizes catheters, facilitates TRI and extracts time and cost from PCI with exceptional patient outcomes.

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With stenting long established as the standard of care for Percutaneous Coronary Intervention (PCI), stent technologies and long-term clinical outcomes have converged. Today health economics is increasingly critical to patient care. Providers are shifting focus toward reducing bleeding complications and readmissions, enhancing patient experience and improving cath lab efficiency.

The SLENDER IDS sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) is designed to meet these needs.

The world’s lowest profile DES*, SLENDER IDS downsizes catheters to facilitate transradial intervention (TRI) across wider subsets of patients, reducing the risk of bleeding complications, endothelial distrubance and spasm. Specialized designs and materials, including best-in-class ASAHI wire tip technology, enable safe direct stenting across challenging anatomy, extracting steps and time from procedures.

Catheter Diameter Indication

And as the only stent approved for use with diagnostic and smaller catheters (0.047” ID), SLENDER IDS allows operators to perform diagnostic angiography and seamlessly continue onto a therapeutic approach through the already engaged diagnostic catheter, streamlining PCI in appropriate lesions.

SLENDER IDS Concept and Design

The concept of combining a guide wire with a balloon catheter is not new; fixed-wire balloons were used in the nascent stages of PCI, and their utility was recognized and valued.  Technological limitations, however, limited their growth and continued use.

SLENDER IDS is the first advance in coronary stent delivery in more than 20 years, representing a new, more efficient approach to PCI.

Slender IDS iteration graphic

By mounting a DES on a wire to create an ‘all-in-one‘ system, catheters are downsized, patient comfort is enhanced, procedures are streamlined and resource consumption is reduced.

From its soft, flexible distal tip incorporating ASAHI wire tip technology to its reinforced distal shaft enhancing pushability, SLENDER IDS incorporates years of improvement in guide wire, balloon, stent and drug coating technologies to create a new paradigm in coronary stenting.

ASAHI Wire Tip Technology

Asahi Logo

ASAHI, recognized the world over as the leader in steerable guide wire technology, designs and manufactures the SLENDER IDS wire tip.  Engineered specifically for SLENDER IDS, ASAHI wire tip technology enables movement just as you imagine it.

Soft, Durable, Precise

With a view to SAFETY FIRST, the soft, uncoated ASAHI wire tip maximizes tactile feedback and minimizes endothelial disturbance when traversing the coronary tree.  Exceptional torque response enhances navigation through distal and tortuous anatomy.

ASAHI-Wire-Tip-Schematic

 

Composite Core Design

ACT ONE, a critical component of Asahi Composite Core Design and ingenious enhancement to the 10 micron core wire, represents the latest Asahi wire technology against which all other wires are measured.

  • Long core wire taper enhances trackability
  • ACT ONE overwrap optimizes tip control and shape retention
  • 1.2 gram tip load* provides an optimal blend of flexibility and support

 

 

Legendary ASAHI Performance

Precise torque transmission and enhanced tactile feedback reduce whip to navigate frontline as well as tortuous vessels and sharp angulations.

With ASAHI wire tip technology redefining the boundaries of guide wire performance, SLENDER IDS provides deliverability like no other DES.

Technologies Designed for Direct Stenting

Hybrid Stent Design

A unique hybrid stent design with variable length struts cut from specially sourced fine grain cobalt chromium allows uniquely tight crimping to achieve profiles as low as HALF the crimped area of conventional stents* without compromise to strut thickness, radial strength or recoil.

 

 

Proprietary Balloon Technology

Low-compliant balloon material  provides a whole new approach to safe and efficient stent delivery.

Specialized delivery balloon technology minimizes unwanted vessel contact during direct stenting.  A proprietary balloon pleating and puffing process creates balloon proximal and distal areas slightly larger in profile than the crimped stent to create a smooth leading edge during stent delivery,

  • Enhancing crossability through tight stenoses
  • Augmenting stent retention
  • Limiting stent-to-vessel contact and adding drug coating protection

Once delivered to the target lesion, higher durometer material and tight tapers limit balloon shoulder growth for safe, precise stent placement,

  • Providing uniform and complete expansion, even in calcified lesions
  • Minimizing ballon-to-vessel contact
  • Allowing multiple, high-pressure inflations

Ensuring optimal stent expansion is critical when direct stenting.  Svelte’s delivery balloon is designed for high pressure inflation(s) to achieve complete stent apposition.  This reduces the need for additional non-compliant post-dilatation balloons and potential for geographic miss.

 

DISCREET Drug Coating

DISCREETa new class of drug coating utilizing an amino acid (PEA) carrier from DSM, a global leader in biomedical materials science and regenerative medicine, provides high mechanical integrity and promotes healing.  Designed for direct senting, it resists damage which may be encountered when crossing calcified and tortuous anatomy, ensuring complete and consistent drug elution to the target lesion.

discreet sem imaging thumbnail

The elastomeric properties of DISCREET drug coating provide the mechanical integrity necessary to direct stent and treat challenging lesions without compromise.  This image represents the overlapped area of stents with DISCREET coating after 10 million cycles.

Once delivered to the target lesion, 213 µg/cm2 of sirolimus is eluted to the vessel wall over 60 days, with full bioresporption of the drug carrier within 12 months.  Unlike other bioresorbable drug carriers, the molecular weight of DISCREET remains constant during resorption, ensuring consistent and complete drug elution without bulk degradation or drug burst release.

Ensuring optimal stent expansion is critical when direct stenting.  Svelte’s delivery balloon is designed for high pressure inflation(s) to achieve complete stent apposition.  This reduces the need for additional non-compliant post-dilatation balloons and potential for geographic miss.

Exceptional Outcomes with Procedural Efficiency

Safe and Durable Outcomes

The Svelte DES technologies deliver outstanding clinical results with low reintervention rates and consistent neointimal suppression across patient subsets.


svelte-des-outcomes


The ultra-low profile and reinforced proximal shaft of SLENDER IDS facilitates TRI and direct stenting, even in complex anatomy.  Despite 50% of investigators in the DIRECT I and II studies being first-time users of the IDS:

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

 

Extract Steps, Time and Cost from Procedures

Svelte technologies optimize the use of preciously scarce resources – time and people.

SLENDER IDS eliminates procedural steps, improving procedural efficiency. Ancillary products typically associated with conventional stenting procedures (guide wires, PTCA balloons and even guiding catheters) are eliminated or reduced, resulting in actual, real-time savings without changing physician practice, even in complex anatomy.

 

Reduce Procedural Steps, Simplify PCI

In observational studies reductions in procedure time by an average of 30% and $119 – $592 in material cost savings per case1-3 were observed using SLENDER IDS.

And as the only DES indicated for use with diagnostic and smaller catheters (0.047″ ID), SLENDER IDS offers the opportunity to downsize catheters, reducing risk of bleeding complications and enhancing patient comfort.

DIRECT-II-Study-Procedural-Efficiencies

Facilitate Transradial Intervention

The clinical benefits of transradial intervention (TRI) and direct stenting are well known.  So too are their ability to streamline procedures and provide cost containment.

Compared with conventional (femoral) stenting, the transradial approach offers the ability to positively impact patients, physicians and health care providers.  Stenting via transradial approach is associated with REDUCED:

  • All-cause mortality4
  • Bleeding complications4,5
  • Vascular complications4,5
  • Time to ambulation6
  • Length of hospital stay6
  • Reduced procedure costs7

For patients, reduced procedural discomfort, bleeding complications, time to ambulation and hospital stays greatly improve the coronary stenting experience.  The transradial approach is overwhelmingly preferred by patients undergoing both radial and femoral access: of 7,021 patients included in the RIVAL study evaluating the effects of radial versus femoral artery access, 90% preferred use of the radial artery as the access site for their next procedure8.

For physicians and health care providers living under increasingly onerous time and budget constraints where emphasis is increasingly placed on extracting costs from procedures while limiting readmissions, TRI can be a meaningful aid in reducing procedure time and cost without compromising long-term outcomes.

As the world’s lowest profile DES, SLENDER IDS downsizes the catheters necessary to complete basic or complex coronary artery stenting.  Lower catheter size facilitates TRI, enhancing patient comfort and reducing risk of bleeding complications.

slender ids logo

LESS IS MORE.

LESS trauma, materials, time and cost.

MORE patient comfort, physician satisfaction and procedural efficiency.

 

Downsize Catheters. Enhance Outcomes. Improve Efficiency.

References:

  1. Khattab A et al. New approach to direct stenting using a novel “all-in-one” coronary stent system via 5 French diagnostic catheters: a pilot study. Cath and Cardiovasc Interv. 2013;82:E403-E410.
  2. Khattab A et al. Svelte Integrated Delivery System performance examined through diagnostic coronary catheter delivery: the SPEED registry. Cath and Cardiovasc Interv. 2015;85:E23-E31.
  3. Devito F et al. Evaluation of the safety and efficacy of the novel Svelte Acrobat Integrated Delivery System via radial approach with 5 French catheters. J Invasive Cardiol. 2015;27:Epub ahead of print.
  4. Agostoni F et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44:349-56.
  5. Kiemeneij F et al. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the european association of percutaneous cardiovascular interventions and working groups on acute cardiac care and thrombosis of the european society of cardiology. EuroIntervention. 2013;8:1242-51.
  6. Cooper C et al. Effect of transradial access on quality of life and cost of cardiac catheterization: a randomized comparison.Am Heart J. 1999 Sep. 138(3 Pt 1):430-6.
  7. Mitchell M et al. Systematic review and cost-benefit analysis of radial artery access for coronary angiography and intervention. Circ Cardiovasc Qual Outcomes. 2012;5:454-462.
  8. Jolly S et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23. 377(9775):1409-20.

 

  DIRECT I clinical study.

 DIRECT II clinical study.

*  Data on file at Svelte.

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.