AFX®2 ENDOVASCULAR AAA SYSTEM

A differentiated unibody approach supported by clinical evidence.

Data speaks louder than words. We’re committed to clinical outcomes that meet your demands. Explore the Five-Year Results of the LEOPARD RCT, now published in JVS. Read It Now

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CLINICAL EVIDENCE

Five-year results from the LEOPARD RCT.

The first-ever head-to-head comparison of EVAR endograft systems in a real-world population.

The AFX2 Endovascular AAA System demonstrated positive 5-year results

and similar outcomes to commercially available endografts in the LEOPARD randomized controlled trial.

The LEOPARD trial is the first RCT comparing an anatomically fixated endograft (AFX/AFX2) to proximal fixation endografts; and demonstrated¹ the following:

99%

Freedom from rupture

97%

Freedom from ARM*

1.5%

AFX/AFX2 type III endoleak rate at 5 years

*ARM: Aneurysm-Related Mortality Freedom-from event estimates were comparable to contemporary proximal fixation endografts.

“Importantly, the comparable performance results from the LEOPARD study between AFX/AFX2 and other endografts align with a recent publication¹ that was authored on behalf of the Society for Vascular Surgery's Patient Safety Organization and used linked registry claims data” Matt Thompson, MD

Review the publication summary:^{^}

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^Publication Summary from BMJ: Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study2

PUBLISHED STUDY

The published study set out to evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data.

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PURPOSE-BUILT DESIGN

Overcome common challenges seen in specific anatomies.

Bifurcated unibody design preserves the native bifurcation and separates graft fixation from the sealing zone

Unibody design mimics the natural aorta, no competing limbs, and enables "up and over" procedures for future endovascular interventions

The AFX2 System's ActiveSeal® technology conforms to the aortic wall

Establishes seal and adjusts to changes that may occur to the aortic neck, allowing the graft material to billow and adapt to the patient's anatomy

Explore the AFX2 System key design features here:

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PROCEDURAL EFFICIENCY

Less Time, Intuitive Design, Greater Efficiency

Shorter times for overall procedure, fluoroscopy and anesthesia as a well as less contrast used on average compared to proximal fixation.¹

79.5

minutes vs. 90.5 Shorter procedure times

16

minutes vs. 18.5 Reduced fluoroscopy time

68

mL vs. 84mL Less contrast volume

Explore how you can save time and resources with the AFX2 System

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CONTACT & RESOURCES

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REFERENCES

Kwolek CJ, Ouriel K, Stucky FS, et al. Five-year results of the Leopard Trial of commercially available endografts. Journal of Vascular Surgery. Published online 2023. doi:10.1016/j.jvs.2023.04.011
Goodney, P, Mao J, Columb J, Suckow B, Schermerhorn M, Malas M, et al. Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study. BMJ 2022;379:e071452.

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Brief Summary Statement for AFX2 System

INDICATIONS: The AFX2 Endovascular AAA System is indicated for endovascular treatment in patients with AAA using a surgical vascular access technique or a bilateral percutaneous technique. The devices are indicated for patients with suitable aneurysm morphology for endovascular repair, including:

Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥ 6.5 mm)

Non-aneurysmal aortic neck between the renal arteries and the aneurysm: with a length of ≥ 15 mm; with a diameter of ≥ 18 mm and ≤ 32 mm; with a neck angle of ≤ 60° to the body of the aneurysm.

Aortic length ≥ 1.0 cm longer than the body portion of the chosen bifurcated model.

Common iliac artery distal fixation site: with a distal fixation length of ≥ 15 mm.; with ability to preserve at least one hypogastric artery; with a diameter of ≥ 10 mm and ≤ 23 mm; with an iliac angle of ≤ 90° to the aortic bifurcation.

Extension stent grafts must have the ability to overlap the bifurcated stent graft by at least 30 to 40 mm proximally and at least 15 to 20 mm distally

CONTRAINDICATIONS: (1) Patients who have a condition that threatens to infect the stent graft; (2) Patients with sensitivities or allergies to the device materials

WARNINGS: The AFX System with Strata (a previous version of the AFX System) is associated with an increased risk of Type III endoleaks and AAA-related adverse events. The AFX System with Duraply (another previous version of the AFX System) may have an increased risk of Type III endoleaks and AAA-related adverse events. It is uncertain whether the increased risk of Type III endoleaks and AAA-related adverse events have been addressed by the AFX2 System (the currently marketed AFX System) because the risk of Type III endoleaks and AAA-related adverse events at 3 years and beyond is not yet established.

PRECAUTIONS: Safety and efficacy has not been evaluated in the following patient populations or conditions: Less than 18 years of age; Pregnant or nursing females; Traumatic aortic injury; Mycotic aneurysms; Uncorrectable coagulopathy; Indispensable mesenteric artery; Leaking, pending rupture or ruptured aneurysms; Pseudoaneurysms resulting from previous graft placement; Revision of previously placed endovascular grafts. This is inclusive of a pre-existing AFX graft (reference Section 4.6 for limited pre-clinical evaluation); Genetic connective tissue disease (e.g., Marfan or Ehlers-Danlos syndrome); Concomitant thoracic aortic or thoracoabdominal aneurysms; Patients with active systemic infections.

POSSIBLE ADVERSE EVENTS related to endovascular treatment in patients with AAA with the AFX2 System include: Amputation; Anesthetic complications; Aneurysm enlargement; Aneurysm rupture and death; Aortic damage, including perforation, dissection, bleeding, rupture, and death; Arterial or venous thrombosis and/or pseudoaneurysm; Arteriovenous fistula; Bleeding, hematoma, or coagulopathy; Bowel complications; Cardiac complications; Claudication; Death; Edema; Embolization (micro and macro) with transient or permanent ischemia or infarction; Endoleak; Stent graft (improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture and perigraft flow); Fever and localized inflammation; Genitourinary complications; Hepatic failure; Impotence; Infection of the aneurysm, device access site, including abscess formation, transient fever, and pain; Lymphatic complications and subsequent attendant problems; Neurologic local or systemic complications; Pulmonary/respiratory complications; Renal complications; Surgical conversion to open repair; Vascular access site complications; Vessel damage; Wound complications and subsequent attendant problems; Vascular spasm or vascular trauma.

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

ATTENTION: See Instructions for Use for a complete listing of Indications, Contraindications, Warnings, Precautions, and Adverse Events.

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

CE marked. Please refer to current product instructions for use.

Endologix is a registered trademark of Endologix LLC in the United States, Europe and Japan, and Rhevera, Rhevera Medical, the Rhevera logo, ALTO, AFX, ActiveSeal, Detour and Pounce are trademarks of Endologix LLC and its subsidiaries. All other trademarks are the property of their respective owners.