Outcomes

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Publications

DIRECT II Randomized, Controlled Safety and Efficacy Study

DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomization. The study demonstrated non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

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DIRECT I First-In-Man DES Study

The DIRECT study is a first-in-man evaluation of the safety and efficacy of the Svelte sirolimu-seluting coronary stent mounted on a fixed-wire, “all-in-one” integrated delivery system (IDS) in patients with de novo coronary artery lesions. The system permits easy delivery, deployment and post-dilatation of a cobaltchromium stent eluting sirolimus from a fully bioabsorbable amino acid coating. The aim of the first-in-man study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans.

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Evaluation of Svelte IDS via Radial Approach with 5F Catheters

Direct stenting using the Svelte Acrobat IDS via radial approach with low-profile catheters is safe and efficacious in select coronary artery disease patients, and its use is associated with potential procedural cost savings. Fifty consecutive patients with 55 lesions were included. The procedure success rate was 98%. The reduced need for additional catheters resulted in a 20% procedural cost reduction. There were no bleeding or vascular complications.

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Svelte IDS Performance Through Diagnostic Catheters: The SPEED Registry

Direct stenting through diagnostic catheters in 48 patients via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessinglesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs.

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Bern DX Catheter Pilot Study

Direct stenting using the Svelte IDS via 5F diagnostic catheters is a viable alternative to conventional stenting in selected patients and is associated with significant cost savings.

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Coronary Stenting Through 4F Diagnostic Catheter

A case report featuring the use of a 4F diagnostic coronary catheter for both the diagnostic angiogram and subsequent intervention in a subtotal occlusion of the RVB. Stenting through 4F diagnostic catheters offers the option (particularly attractive for radial approach) to stent coronary arteries through a puncture hole as small
as 1.4 mm when omitting the introducer sheath.

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Double-Vessel Coronary Stenting via 5F Diagnostic Catheters

A case report featuring the use of 5F diagnostic coronary catheters for both the diagnostic angiogram and subsequent double-vessel PCI with primary stent implantation of the novel Svelte IDS stent-on-a-wire in the mid LAD and proximal RCA.

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Complex Made Easy: LAD Trifurcation Treated with a Single Device

Coronary trifurcation lesions are a complex subset of lesions. This case report features treatment of a trifurcation lesion involving the LAD and 2 diagonal branches with a single device, the novel SVelte IDS stent-on-a-wire.

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Svelte Bare Metal Stent IDS First-In-Man Study

The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the first-in-man study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans.

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Svelte IDS: a Technical Report

The Svelte IDS is a high-performance coronary stent delivery system consisting of a balloon expandable stent pre-mouted on a single-lumen fixed-wire delivery system with low-compliant balloon.

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Svelte IDS Design and Overview

The Svelte IDS combines a thin strut (81μ) balloon-expandable stent mounted on a delivery system with a low-compliant nylon balloon and guidewire tip. The system is designed to facilitate percutaneous coronary intervention by reducing time/cost and minimising peri-procedural complications and therefore benefit a large number of patients in daily practice who are currently labelled as unfavorable for direct stenting.

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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.