Technology

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DIRECT RX Rapid-Exchange Delivery System

Incorporating specialized balloon and drug coating technologies, DIRECT RX is the only rapid-exchange DES specifically designed for direct stenting.

Direct RX logo

Compared with conventional (lesion pre-dilatation) stenting, direct stenting offers the ability to streamline procedures, positively impacting patients, physicians and health care providers.

For patients, direct stenting is associated with REDUCED:

  • Death1
  • Myocardial Infarction (MI)1
  • Target Lesion Revascularization (TLR)2
  • Restenosis2,3
  • Endothelial denudation4
  • Microvascular Disfunction5
  • Radiation exposure6
  • Contrast use6

For physicians and health care providers living under budget constraints with increasing emphasis placed on cost containment without compromise to patient care, direct stenting can be a meaningful aid in reducing procedure time and cost.

Limitations of current stent technology, however, in part prevent greater uptake of the direct stenting approach to treat appropriate lesions.

DIRECT RX was specifically designed to allow safe and reliable direct stenting across greater patient and lesion subsets.

The DIRECT RX Concept and Design

Clinical circumstances (such as single vessels with multiple lesions) or simple physician preference may demand use of a standard, guide-wire based approach to Percutaneous Coronary Intervention (PCI) over SLENDER IDS.

In designing DIRECT RX, Svelte engineers created a rapid-exchange system incorporating key features found with SLENDER IDS and critical to enhancing direct stenting – lower profiles, specialized balloon technologies and high integrity drug coating.

Direct Stent More Lesions with Confidence

DIRECT RX is the first rapid-exchange stent delivery system specifically designed for direct stenting.

Incorporating a novel stent design capable of crimping to ultra-low profiles, robust balloon designs to enhance stent delivery and deployment and drug coating technologies with high mechanical integrity, DIRECT RX establishes a higher standard for rapid exchange DES systems.

A highly trackable, pushable and low profile stent delivery catheter provides optimal force transfer across the entire system for smooth delivery, even through tortuous anatomy.  Specialized tapered tip technology designed for difficult lesion crossing facilitates entry to tight and calcified stenoses.

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.

 

2.5 x 18mm Crimped Stent Comparison

 

Proprietary Balloon Technologies

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

 

Low-compliant balloon material

To minimize unwanted stent contact during direct stenting, Svelte developed specialized delivery balloon technology.  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

DISCREET,a 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.

Exceptional and Sustained Outcomes

Safe and Durable Outcomes

The Svelte DES delivers outstanding clinical results, demonstrating low reintervention rates and consistent neointimal suppression across patient subsets.


svelte-des-outcomes


Pristine angiographic appearance, reviewed and reported by independent core labs, coupled with NO report of death or stent thrombosis in any Svelte DES study, demonstrate the exceptional safety and efficacy of the Svelte DES.

 

DIRECT II Trial 2-Year Clinical Results

Optimize Direct Stenting

The clinical benefits of direct stenting are well known. So too is its ability to streamline procedures and provide cost containment.

For physicians and health care providers living under onerous time and budget constraints where emphasis is increasingly placed on containing costs and  limiting readmissions, direct stenting appropriate lesions can shorten procedures, limiting radiation exposure to patient and physician while improving lab turnover.

As the only DES designed for direct stenting, DIRECT RX provides the option of direct stenting more lesions quickly and safely, providing low profiles, excellent deliverability, balloon technology designed for safe deployment and post-dilatation at high pressures and tough drug coating capable of maintaining integrity in more highly calcified lesions.

direct rx logo

DIRECT RX is the first rapid-exchange stent delivery system with new technologies specifically designed for direct stenting.

 

DIRECT stent more lesions with confidence.

References:

  1.  Piscione F et al. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? results from a meta-analysis of 24 randomised controlled trials. 2010;96:588-594.
  2. Ormiston J et al. Direct stenting with the taxus liberte drug-eluting stent: results from the taxus atlas direct stent study. J Am Coll Cardiol Intv. 2008;1(2):150-160.
  3. Cuisset T et al. Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation. Am J Cardiol. 2008;51:1060-5.
  4. Caluk J et al. Direct coronary stenting in reducing radiation and radiocontrast consumption. Radiol Oncol. 2010 Sep;44(3): 153-7.
  5. Burzotta F et al. Comparison of outcomes (early and six-month) of direct stenting with conventional stenting (a meta-analysis of ten randomized trials). Am J Cardiol. 2003;91:790-6.
  6. Brueck M et al. Direct coronary stenting versus predilatation followed by stent placement. Am J Cardiol. 2002;90:1187-1192.

 

 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.