Ovation iX

Product catalog summary

Overview: The document discusses the Ovation iX™ Abdominal Stent Graft System, highlighting its features, benefits, and clinical performance in treating abdominal aortic aneurysms (AAA). It emphasizes the system's low-profile design, flexibility, and ability to treat a wide range of anatomies with minimal vessel trauma.

Key Features:

Ultra-Low Profile System: The Ovation iX™ delivery system has a 12F inner diameter, allowing navigation through narrow and tortuous anatomies, facilitating access to small vessels.
CustomSeal™ Technology: The polymer-filled O-ring conforms to vessel wall irregularities, providing a watertight seal without exerting chronic outward force, thus protecting the aortic neck.
Staged Deployment: The system allows for precise placement with eight radiopaque markers and repositioning capabilities to ensure accurate deployment.

Clinical Performance:

Proven Patency: The Ovation iX iliac stent grafts demonstrate a low limb occlusion rate of 1.2% at one year, compared to 2.7% with Medtronic’s Endurant IDE.
Hostile Anatomy Adaptability: The helical nitinol stent is kink-resistant, and the low permeability PTFE reduces thrombosis and limb occlusions.
Patient Access: In the Ovation Pivotal trial, 40% of patients had challenging anatomies with access vessels <6 mm or neck length <10 mm, achieving a 0% major adverse event (MAE) rate at 0 to 30 days.

Indications and Contraindications:

The system is indicated for patients with suitable vascular morphology for endovascular repair, including specific proximal and distal landing zone requirements.
Contraindications include conditions that threaten graft infection and known sensitivities to device materials.

Conclusion: The Ovation iX™ system offers a minimally invasive solution for AAA treatment, with a focus on precise placement, adaptability to challenging anatomies, and reduced risk of complications.

Catalog excerpts

Access More Patients. Customize Each Seal. Ovation iX™ Abdominal Stent Graft System

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The Least Invasive Path Towards Proven Patency ULTRA LOW PROFILE TO EASE ADVANCEMENT The flexible, ultra-low 12F ID Ovation iX™ delivery system enables you to navigate through tortuous and narrow anatomies, access small vessels, and deliver a stent graft to the widest on-label range of anatomies with ease and less vessel trauma. Clinically proven occlusion rate at 1 year.1 Staged deployment of suprarenal stent allows easier, precise placement CustomSeal™ The right profile for narrow access Low profile, kink-resistant catheter built for maneuverability and flexibility DEMONSTRATED PATENCY EVEN...

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Conformability Without Compromise Stable PROVIDE A CUSTOMSEAL™ FOR EACH PATIENT Create a customized seal that conforms to vessel wall irregularities through the CustomSeal™ polymer technology. neck diameter at 4 years PROTECT THE NECK The O-ring design provides a watertight, circumferential seal at the midpoint of the sealing ring, 13 mm below the inferior renal artery. It exerts no chronic outward force and insulates the neck from blood pressure, which results in stable neck diameter.3 OVATION SYSTEM Polymer is injected in a low-viscosity liquid state, allowing sealing ring to conform to irregular...

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Ovation iX Offers Simplified Delivery and Precise Placement CROSSOVER LUMEN FOR OVATION IX — THE SOLUTION TO GATE CANNULATION The crossover lumen provides an alternative to retrograde cannulation. Designed for predictable procedure times, increased efficiencies, and reduced ancillary device usage, the crossover lumen simplifies the delivery of Ovation iX™. SIMPLE, STAGED DEPLOYMENT PROMOTES PRECISE PLACEMENT With a simple, staged deployment and eight radiopaque markers, the Ovation iX system is designed to deliver precise placement and accurate deployment. CROSS-SECTION VIEW: 0.018” wire exits...

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ACCESS MORE PATIENTS, CUSTOMIZE EACH SEAL In the Ovation Pivotal trial, approximately 40% of patients (66/161) treated had access vessels <6 mm in diameter, aortic neck length <10 mm, or both. Patients within this anatomically challenging group had a 0% MAE rate at 0 to 30 days and a 3.0% MAE rate at 31 to 365 days.1 13 Patients Neck length <10mm Minimum access vessel <6mm Both criteria NOTES: 1. Ovation® pivotal trial reintervention rate due to Ovation limb occlusions, N=159. Data as of July 25, 2014. 2. Makaroun, et al. JVS 2011: Sept 601-08. One year outcomes of the United States regulatory...

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