1. Data on file D000410086_A, D000485394_A
2. Davies JE, et al., Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.
3. Gotberg M, et al., iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823.
4. Comparisons to Verrata Plus. Data/report internally on file or internal company’s data on file. Verification Report, D000410086/A.
5. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision-making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018.
6. A. Maehara, M. Matsumura, Z.A. Ali, G.S. Mintz, G.W. Stone. IVUS-guided versus OCT-guided coronary stent implantation. J Am Coll Cardiol Img, 10 (2017), pp. 1487- 1503.
7. Choi K, et al. Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC: Cardiovascular Interventions. Mar 2019, 4281; DOI: 10.1016/j.jcin.2019.01.227.6.Co-registration tools available within IntraSight 7 configuration via SyncVision.
8. Co-registration tools available within IntraSight 7 configuration via SyncVision
Tack Endovascular System important safety information:
The Tack endovascular system (6F, 3.5 - 6.0 mm and 4.0 - 8.0 mm) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm and 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
The Tack endovascular system (4F, 1.5 - 4.5 mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Contraindications for Use:
The Tack Endovascular System is contraindicated for the following:
1. Patients with residual stenosis in the treated segment equal to or greater than 30% after PTA.
2. Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device.
3. Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol).
4. Patients unable to receive standard medication used for interventional procedures such as anticoagulants, contrast agents and antiplatelet therapy
Potential complications include but are not limited to: access failure or abrupt closure; allergic/anaphylactoid reaction to anticoagulant and/or antithrombotic therapy or contrast medium; allergic reaction to Nitinol; amputation of lower extremity; anemia; angina / coronary ischemia / myocardial infarction; arrhythmia; arterial occlusion/(re)stenosis/dissection/thrombus; arterial spasm; arteriovenous fistula; blue toe syndrome; claudication or rest pain, worsened; death; disseminated intravascular coagulation; embolism; emergent repeat hospital intervention; fever; gangrene; gastrointestinal bleed from anticoagulation / antiplatelet medication; hematoma / hemorrhage; hypotension / hypertension; inadvertent venipuncture; infection / abscess at insertion site / cellulitis; inflammation; multi-organ failure; pain; pseudoaneurysm; renal insufficiency or failure; respiratory distress or failure; reperfusion pain; septicemia / bacteremia (sepsis); swelling / edema, peripheral; tachycardia; Tack implant embolization; Tack implant migration; Tack implant occlusion / restenosis; tissue necrosis; trauma to adjacent structures; stroke / TIA (hemorrhagic / embolic); and vascular complications which may require surgical repair.
Caution: Federal law restricts this device to sales by or on the order of a physician.
