Balloon Technology Designed for Direct Stenting

Svelte proprietary balloon material enhances direct stenting and allows for controlled, multiple, high-pressure inflations.

Direct stenting is associated with improved clinical outcomes and enhanced procedural efficiencies. Yet, it is typically used in only 25-40% of stenting procedures. Primary among the reasons for this are operator concerns regarding proper stent sizing and achieving complete stent expansion with uniform drug elution, especially in vessels with calcification.

The SLENDER IDS and DIRECT RX platforms incorporate two unique and proprietary balloon technologies specifically designed to address these concerns. These technologies enable safe stent delivery and multiple, high-pressure balloon inflations, if necessary, to optimize outcomes with direct stenting across a wide range of lesions.

Low-Compliant, Durable Balloon Material

Navigation, particularly through tortuous anatomy, can bring the leading edge of a stent into contact with vessel calcification and the arterial wall. This may alter the profile and drug coating of a stent.

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

Compared with conventional stent delivery systems, Svelte low-compliant delivery balloons limit balloon growth at the stent edges to mitigate risk of dissection, especially when deploying at higher pressures.

Conventional Delivery Balloon

Svelte Delivery Balloon

Inflate to Higher Pressures During Stent Deployment

Realizing full stent expansion with complete vessel wall apposition is critical to achieving optimal clinical outcomes. Incomplete stent apposition occurs for a variety of reasons when direct stenting, including underestimation of vessel size (using an undersized stent) or lack of preliminary vessel expansion / lesion preparation. High-pressure dilatation is often necessary to ensure optimal stent expansion and lumen gain, particularly in calcified anatomy.

Designed for direct stenting, Svelte delivery balloons are composed of durable, low-compliant nylon material, generating a compliance curve more akin to Non-Compliant (NC) balloons than traditional stent delivery balloons.

3.0 mm Balloon Compliance^*

Svelte balloon technology provides controlled growth and the flexibility to safely post-dilate to higher pressures with multiple inflations to ensure optimal stent expansion. This optimizes clinical outcomes while reducing the need for additional NC post-dilatation balloons and potential for geographic miss.

Outcomes in Clinical Studies

Excellent results with direct stenting in a controlled setting were observed in the DIRECT II study:^‡

Patients Attempting Direct Stenting with Svelte Stent	N=100
Direct Stenting Success	98%
Stent Deployment / Post-Dilatation Using Only Svelte Balloon	83%
Type B2/C Lesions	43%
Moderate-Heavy Calcification	22%
Dissection – Flow Limiting	0%

Excellent long-term outcomes were achieved in multiple clinical studies. Realize the benefits of direct stenting with Svelte balloon technologies.

Direct Stent more lesions with confidence.

* Data on file at Svelte.

^‡ 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.

Technology