Expanding EVAR

The Ovation® Abdominal Stent Graft Platform is FDA­-approved to treat the widest range of anatomies with an innovative, less invasive, clinically proven solution for Endovascular Aortic Repair (EVAR).

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Customized Seal

Customized seal for each patient

With the Ovation® Abdominal Stent Graft Platform, physicians create a customized seal by filling the graft’s conformable O-rings with CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo.

The O-ring conforms to vessel wall irregularities and creates a circumferential seal at the mid-point of the sealing ring, located 13 mm below the inferior renal artery.

The ovation platform protects the neck

The sealing ring technology exerts no chronic outward force and insulates the neck from blood pressure. Patients treated with the Ovation Platform in the pivotal study had no neck dilatation and no late Type 1 endoleaks at 3 years.1,2

1. Core Lab Data. Ovation Global Pivotal Trial. Data as of July 25, 2014.

2. Neck dilatation in proximal neck defined as growth > 3 mm 10 mm below renals, 13 mm below renals and 15 mm below renals. Data as of July 25, 2014.

Stent Graft Comparison:

Ovation Abdominal Stent Graft

Ovation Abdominal Stent Graft

3. Neck dilatation in proximal neck defined as growth > 3 mm 10 mm below renals, 13 mm below renals and 15 mm below renals. Data as of July 25, 2014.

Self Expanding Stent Graft

Self Expanding Stent Graft

4. Rodway Eur J Endovasc Surg 2008; 35: 685-93 EVAR: N = 67, Open: N = 56. Devices: Cook Zenith and Medtronic Talent.
5. Monahan JVS 2010: 52: 303-7 N = 46. Device: Cook Zenith.

Less Invasive

Fast, safe access

At 14F OD, the ultra low profile system enhances deliverability and minimizes vessel trauma, allowing fast, safe access to the aneurysm.

The low profile advantage

A delivery catheter becomes more flexible as the diameter decreases. The Ovation® platform is built for maneuverability, which is critical in navigating through narrow and tortuous anatomies.

The ultra low profile system, combined with PTFE covered, kink-resistant iliac limbs, facilitates the treatment of patients with narrow distal aortas.

Narrow Access:

Narrow Access

3 year follow-up

Tortuous Anatomy

Tortuous Anatomy

3 year follow-up

Narrow Distal Aorta

Narrow Distal Aorta

Pre-case

3 year follow-up

Precise Placement

Pinpoint accuracy is essential to ensure procedural predictability and successful outcomes, especially in challenging anatomies. With a simple, staged deployment, the Ovation® Platform is designed to deliver precise, predictable placement.

During Deployment

During Deployment

Post-Deployment

Post-Deployment

Procedural Predictability

Confidence, Delivered

  • The integrated cross-over lumen facilitates reliable contralateral gate access even in challenging anatomies.
  • The system is designed for predictable procedure times, increased efficiencies and reduced ancillary device usage.
  • On demand: There when you need it, imperceptible when you don’t.

Giving You Options

  • The cross-over lumen enhances ease of use by providing an alternative to retrograde cannulation.
  • The PTFE cross-over lumen is entirely withdrawn with the Ovation iX aortic body delivery system.

Proven Patency

Ovation® iliac stent grafts are engineered to promote patency even in hostile anatomy.

  • Clinically Proven - 1.2% limb occlusion rate at one year 1

  • Highly Conformable - Designed to be kink resistant even in the most tortuous iliac anatomy

  • Expanded Options - The Ovation iX broader size matrix enables treatment of a wider range of AAA anatomies: Flared limbs up to 28mm diameter and limb lengths up to 160mm

 

1. Ovation® pivotal trial reintervention rate due to Ovation limb occlusions, N=159. Data as of July 25, 2014.

Instructions for Use

Ovation iX Instructions for Use can be downloaded by clicking HERE.

Ovation Prime® with Ovation iX Iliac Stent Graft Instructions for Use can be downloaded by clicking HERE.

Ovation Prime Instructions for Use can be downloaded by clicking HERE.

Ovation® Instructions for Use can be downloaded by clicking HERE.

Indications, Contraindications and Caution Statement

INDICATIONS FOR USE: The TriVascular Ovation platform (including Ovation, Ovation Prime and/or Ovation iX Abdominal Stent Graft Systems) is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories; proximal aortic landing zone: with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery, and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; distal iliac landing zone: with a length of at least 10 mm, and with an inner wall diameter of no less than 8 mm and no greater than 25 mm (no greater than 20 mm for Ovation/Ovation Prime).

CONTRAINDICATIONS: The systems are contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with known sensitivities or allergies to the device materials (including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, fluorinated ethylene propylene [FEP] or nitinol). Also consider the information in Section 4 Warnings and Precautions of the systems’ Instructions for Use.

Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

NOTE: Not all product components are available in every country. Please consult with your TriVascular representative to confirm product availability.