Important Safety Information

Indications and Important Safety Information for the DETOUR™ System

INDICATIONS: The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200mm to 460mm in length with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.

CONTRAINDICATIONS: The DETOUR System is contraindicated in patients with: (1) a distal common femoral artery (CFA) <7 mm in diameter; (2) increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy; (3) untreated flow-limiting aortoiliac occlusive disease; (4) lack of patent single vessel tibial runoff to ankle; (5) known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed; (6) known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed.

WARNINGS: In the DETOUR2 Clinical Study, venous event rates were higher in females than males. This should be considered in patient selection and post-procedure management. Inadvertent, partial, or failed deployment or migration of the stent graft may require surgical intervention.

PRECAUTIONS: (1) Consider recent DVT history in the target limb in case planning and post-procedure anticoagulation as use of the DETOUR System uses a bypass conduit within the femoral vein. (2) Antiplatelet medication should be initiated prior to placement of the stent graft. (3) Effective dual antiplatelet therapy should be maintained following the procedure at a dosage deemed appropriate by the physician. (3) A knee prosthesis may prevent successful and accurate ENDOCROSS Device needle deployment.

POSSIBLE ADVERSE EVENTS related to percutaneous transmural arterial bypass with the DETOUR System include: access vessel occlusion; amputation; aneurysm or pseudoaneurysm; arteriovenous fistula; bleeding complications; death; device or deployment malfunction/failure; drug reactions to antiplatelet agents or contrast medium; edema; embolism; fever in absence of infection; hemorrhage or hematoma; hypotension/hypertension; infection; malposition; migration; myocardial infarction; pain; peripheral ischemia; renal insufficiency or failure secondary to contrast medium; shock; side branch vessel occlusion; stenosis or occlusion; stroke or transient ischemic attack; thrombosis; vessel wall trauma; vessel spasm; venous flow disruption; worsening claudication.

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.

https://eifu.endologix.com/hcp/endologix/all?keycode=ELX10058

Indications and Important Safety Information for Alto Abdominal Stent Graft System

INDICATIONS: The Alto™ Abdominal Stent Graft System is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following:

Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories,

A proximal aortic landing zone for the sealing ring 7 mm below the inferior renal artery.

An aortic sealing zone comprised of healthy aorta defined as: (1) Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7 mm below the inferior renal artery; (2) Lack of significant calcification at the level of 7 mm below the inferior renal artery; (3) Conicity < 10% as measured from the inferior renal artery to the aorta 7 mm below the inferior renal artery, (4) An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery, and (5) An aortic angle of ≤ 60 degrees.

A 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.

CONTRAINDICATIONS: (1) Patients who have a condition that threatens to infect the graft. (2) Patients with known sensitivities or allergies to the device materials including polytetrafluoroethylene (PTFE), polyethylene glycol (PEG)-based polymers, contrast agents, fluorinated ethylene propylene (FEP), titanium, nickel, platinum, or iridium.

WARNINGS: This device is not recommended in patients who: have or are suspected of having an active systemic infection; cannot tolerate contrast agents necessary for intra-operative and post-operative follow up imaging; and/or have sensitivities or allergies to the stent graft system materials, antiplatelets or anticoagulants; have creatinine level of >2.0mg/dL; have unstable angina and/or myocardial infarction or cerebral vascular accident within 3 months prior to implantation; and/or exceed weight and/or size limits necessary to meet imaging requirements.

PRECAUTIONS: (1) Vessels that are significantly calcified, occlusive, stenotic, tortuous, aneurysmal, or thrombus-lined may preclude placement of the device. (2) Irregular calcification, plaque, and/or thrombus thickness > 8 mm at any point along the aortic circumference of the seal zones may compromise the fixation and/or sealing at the implantation sites.

POSSIBLE ADVERSE EVENTS: Acute and chronic renal failure, renal microembolism, renal insufficiency, renal artery occlusion, contrast toxicity; Amputation; Anesthetic complications and subsequent attendant problems (aspiration); Aneurysm enlargement or rupture; Aortic damage; Aortocaval fistulae; Aortoenteric fistulae; Blood or bleeding; Bowel events; Cardiac events and subsequent attendant problems; Cerebral events (local or systemic) and subsequent attendant problems; Claudication; Contrast toxicity/anaphylaxis; Death; Device events such as deployment or device malfunction, stent fracture, loss of stent graft system component integrity, graft twisting and/or kinking, graft material wear, dilation, erosion, puncture, endograft occlusion, migration, dislodgement; Edema; Embolic and thrombotic events (with transient or permanent ischemia or infarction); Endoleaks (or peri-graft flow); Fever; Gastrointestinal complications; General procedural discomfort; Generalized inflammatory response; Genitourinary complications and subsequent attendant problems; Hematoma (surgical); Hepatic failure; Hypersensitivity (severe allergic reaction and/or anaphylactoid response) to x–ray contrast dye, anti-platelet therapy, device materials including polytetrafluoroethylene (PTFE), polyethylene glycol (PEG)-based polymers, contrast agents, fluorinated ethylene propylene (FEP), titanium, nickel, platinum or iridium; Insertion and other vascular access site complications; Impotence/ sexual dysfunction; Infection; Lymphatic complications and subsequent attendant problems such as lymphocele, lymph fistula; Multi-system organ failure; Neoplasm; Open surgical conversion; Operative and post–operative bleeding and hemorrhage, coagulopathy; Paralysis (temporary or permanent); Pericarditis; Pneumothorax; Polymer leak with hypersensitivity reaction; Prosthesis occlusion/stenosis; Pseudoaneurysm; Pulmonary/respiratory events and subsequent attendant problems; Radiation injury, late malignancy; Sepsis; Seroma; Shock; Spinal neurological deficit; Stenosis/occlusion of native vessel;; Vascular spasm or vascular injury/trauma including damage to blood vessels and surrounding tissues, atherosclerotic ulcer, vessel dissection, perforation, plaque dissection, stenosis, pseudoaneurysm, vessel occlusion, embolization, ischemia, tissue loss, limb loss, gangrenous disease.

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.

https://eifu.endologix.com/hcp/endologix/all

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.

https://eifu.endologix.com/hcp/endologix/all

Indications and Important Safety Information for the Pounce Thrombectomy System

Indications: The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

Contraindications: (1) The device is contraindicated for use in patients who cannot receive recommended intravenous anticoagulant therapy. (2) The device is not for coronary or neurovascular use. (3) The device is not intended to be deployed in vessels with previously implanted devices.

Warnings: (1) The device has not been tested for venous applications. (2) Safety and effectiveness has not been established in pediatric patients (<18 years of age).

Precautions: Pre-clinical testing with this device showed the potential for clot formation in the absence of anticoagulation. Appropriate anticoagulation therapy should be administered to reduce the potential for thrombus formation on the device. Use in conjunction with other thrombolytic therapies, other thrombectomy devices, or other therapeutic devices in the same procedure or following treatment has not been evaluated.

Adverse Events: Possible complications associated with catheterization with the Pounce Thrombectomy System include the following: allergic reaction; bleeding complications; blood vessel spasm; distal embolization; hematoma; infection; intra-vessel thrombosis, occlusion; pain at puncture site; vessel perforation, rupture, aneurysm, pseudoaneurysm, or dissection; high blood pressure; hyperglycemia.

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.