Important Safety Information (EU)

Santreva-ATK Endovascular Revascularization Catheter

Intended Purpose
The Santreva-ATK endovascular revascularization catheter is intended for crossing stenotic lesions, including Chronic Total Occlusions (CTOs), together with plaque compression and channel formation in peripheral arteries (e.g., femoropopliteal arteries) to facilitate placement of a guidewire in the true lumen after crossing and prepare the vessel for further treatment.

Contraindications

  • Not intended for use in the renal, mesenteric, cerebral, or coronary vasculature.
  • Contraindicated for use in patients with known hypersensitivity to nickel or titanium.
  • Contraindicated for use in patients who cannot tolerate anticoagulant or anti-platelet therapy.
  • Contraindicated for use in patients with unresolved bleeding disorders.

Warnings

  • Do not use Santreva-ATK catheter with hydrophilic coated guidewires.
  • Do not use in a target lesion located in a bypass graft or stent (i.e., in-stent restenosis).
  • Before the insertion of the device, administer appropriate anti-coagulant.
  • Santreva-ATK catheter is intended for single patient use only. Do not re-sterilize or reuse, as this can result in 
compromised device performance.
  • Do not use if the package is opened or damaged.
  • Do not use after the “Use By” date on the product label.
  • After use, dispose of product and packaging in accordance with hospital, administrative, and/or government policy.

Precautions

  • Do not use without completely reading and understanding the Instructions for Use (IFU).
  • Store device at ambient conditions in a catheterization lab or storage room.
  • Do not expose the catheter to organic solvents (e.g., alcohol).
  • The outer box is not a sterile barrier. The pouch contained within the outer box is the sterile barrier. Only the contents of the inner pouch are sterile. The outside surface of the inner pouch is not sterile. Do not remove the contents of pouch until immediately prior to the use of device.
  • Excessive bending or kinking of the catheter may affect performance.
  • Torquing the catheter excessively may cause damage to the product.
  • If the catheter is believed to become kinked, unintentionally damaged, and/or structural integrity of the device is 
thought to be impacted, withdraw the catheter and replace with a new unit to continue with the procedure.
  • If strong resistance is felt during manipulation, determine the cause of the resistance before proceeding further. If the cause cannot be determined, withdraw the catheter.
  • If the device is withdrawn during the CTO crossing procedure, inspect the device tip and catheter shaft for damage 
prior to reinsertion into the patient.

Potential Complications

The use of Santreva-ATK carries the risks associated with peripheral vascular angioplasty, including thrombosis, vascular complications, and/or bleeding events. The risks associated with standard PTA procedures are reported in the published literature and include the following:

  • Access site pain
  • Allergic reaction to contrast medium, anticoagulant, antithrombotic therapy, or device materials
  • Aneurysm
  • Arrhythmias
  • Arterial dissection
  • Arterial perforation
  • Arterial rupture
  • Arterial spasm
  • Arteriovenous fistula
  • Bleeding complications
  • Concomitant medication complications 
(drug reactions, bleeding from antiplatelet/anti‑coagulation agents)
  • Death
  • Emboli (air, tissue, thrombus or 
atherosclerotic emboli)
  • Emergency or non‑emergency arterial 
bypass surgery
  • Entry site complications
  • Fever
  • Fracture of the guidewire or any component of the device that may or may not lead to device embolism, serious injury or surgical intervention
  • Hematoma
  • Hemorrhage at the vascular access site
  • Hemolysis
  • Hypertension
  • Hypotension
  • Infection
  • Ischemia
  • Myocardial infarction
  • Pseudoaneurysm
  • Renal failure
  • Restenosis of the treated segment
  • Sepsis
  • Shock/pulmonary edema
  • Thrombosis
  • Total occlusion of the peripheral artery
  • Vascular complications which may require surgical repair (conversion to open surgery)

Expected Clinical Benefits

The expected clinical benefits of Santreva-ATK when used as intended in peripheral vessels (e.g., femoropopliteal arteries) of patients with Peripheral Arterial Disease (PAD) include:

  1. Crossing stenotic lesions, including Chronic Total Occlusions (CTOs).
  2. Plaque disruption and compression without risk of embolism, flow-limiting dissection, and major perforation.
  3. Formation of an intraplaque and angiographically visible channel.
  4. Facilitation of guidewire placement in distal true lumen through the device.
  5. Leaving the lesion and vessel prepared one step for further imaging and final treatment.

One-step vessel preparation with Santreva-ATK enables further endovascular treatment and can also lead to shorter procedure times. These potential clinical benefits of the Santreva-ATK device are intended to be achieved with a high degree of technical success and low occurrence of periprocedural complications.

Instructions for Use
Please refer to the Instructions for Use (IFU) for complete safety, performance, and clinical benefits information.
www.angiosafe.com/instructions-for-use/