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ELCA and ELCA X-80 important safety information
Indications for use: The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System or Philips Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. Adjunctive balloon angioplasty was performed, at the clinical investigator’s discretion, for 85% of the lesions treated. The following Indications for Use, Contraindications and Warnings have been established through multicenter clinical trials. Clinical experience has provided reasonable assurance that the multifiber laser catheter models are safe and effective for the following indications:Occluded saphenous vein bypass graftsOstial lesionsLong lesions (greater than 20mm in length)Moderately calcified stenoses (Heavily calcified stenoses are those lesions that demonstrate complete calcification when identified under fluoroscopy by angiography prior to the procedure. Moderately and slightly calcified stenoses are all others.)Total occlusions traversable by a guidewireLesions which previously failed balloon angioplasty (This includes those lesions that were treated unsuccessfully by PTCA. Lesions that have undergone a complicated PTCA procedure are not included in this category.)Restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. (not indicated for X-80 models)These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography.
Contraindications: Lesion is in an unprotected left main arteryLesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverseGuidewire cannot be passed through the lesionLesion is located within a bifurcationPatient is not an acceptable candidate for bypass graft surgeryPatient has acute thrombosis (applicable to X-80 models only)Patient has experienced an acute myocardial infarction (applicable to X-80 models only)Patient has ejection fraction of less than 30% (applicable to X-80 models only)See complete IFU for more information before attempting use of ELCA.
Potential adverse events: Use of the Spectranetics CVX-300 Excimer Laser System or Philips Laser System may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death.No long-term adverse effects of ELCA are known at this time.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
AngioSculpt RX PTCA scoring balloon catheter
Indications: The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
Contraindications: The AngioSculpt catheter should not be used for the following: Coronary artery lesions unsuitable for treatment by percutaneous revascularization. Coronary artery spasm in the absence of a significant stenosis.
Warnings: Administer appropriate antiplatelet, anticoagulant and coronary vasodilator therapy, consistent with institutional practice for coronary stent procedures, during and after the procedure. This device is intended for single (one) use only. Do not desterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of inappropriate desterilization and cross contamination. For use in de novo or in-stent restenosis (ISR) lesions, the inflated diameter size of the balloon should approximate the vessel diameter size just proximal and distal to the stenosis, in order to reduce potential vessel damage. When used to pre-dilate the lesion prior to pre-planned stenting, the catheter should be one size smaller than the estimated vessel diameter (e.g., a 2.5 mm diameter device should be used in a vessel estimated to have a 3.0 mm diameter). PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Do not exceed the rated burst pressure (RBP) during balloon inflation. The RBP is based on results of in-vitro testing. At least 99.9% of the balloons (with 95% confidence) will not burst at or below their RBP. Use of a pressure monitoring device is recommended to prevent over-pressurization. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potential cardiovascular injury or life-threatening complication. Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. Use the device prior to the expiration date specified on the package.
Precautions: Take extra care when using the Angio Sculpt catheter to treat a lesion distal to a freshly deployed stent. This precaution is particularly applicable to a drug-eluting stent so as to minimize the risk of damage to the stent coating. Prior to angioplasty, examine the catheter to verify functionality, catheter integrity and to ensure that its size and length are suitable for the specific procedure for which it is to be used. Only physicians trained in the performance of percutaneous transluminal coronary angioplasty should use the Angio Sculpt catheter. Do not rotate the catheter shaft in excess of 180 degrees when the tip is constrained. Do not rotate the catheter lure hub in excess of five (5) turns during use. Do not advance or retract the Angio Sculpt catheter over the floppy portion of the guidewire. Catheter manipulation, including advancement and retraction, should be performed by grasping the catheter shaft. If unusual resistance is felt when the catheter is being manipulated or if it is suspected that the guidewire has become kinked, carefully remove the entire catheter system (Angio Sculpt catheter and steerable guidewire) as a unit. If fluoroscopic guidance indicates that the Angio Sculpt catheter has advanced beyond the end of the guidewire, withdraw the catheter and reload the wire before advancing again.
Possible adverse effects: Possible adverse effects include, but are not limited to, the following: Death; Heart Attack (acute myocardial infarction); Total occlusion of the treated coronary artery; Coronary artery dissection, perforation, rupture, or injury; Pericardial tamponade; No/slow reflow of treated vessel; Emergency coronary artery bypass (CABG); Emergency percutaneous coronary intervention; CVA/stroke; Pseudoaneurysm; Restenosis of the dilated vessel; Unstable angina; Thromboembolism or retained device components; Irregular heart rhythm (arrhythmias, including life-threatening ventricular arrhythmias); Severe low (hypotension)/high (hypertension) blood pressure; Coronary artery spasm; Hemorrhage or hematoma; Need for blood transfusion; Surgical repair of vascular access site; Creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); Drug reactions, allergic reactions to x-ray dye (contrast medium); Infection.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
- Davies JE, et al., DEFINE-FLAIR: A Multi- Centre, Prospective, International, Randomized, Blinded Comparison of Clinical Outcomes and Cost Efficiencies of iFR and FFR Decision-Making for Physiological Guided Coronary Revascularization. New England Journal of Medicine, epub March 18, 2017.
- 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.
- Patel M. “Cost-effectiveness of nstantaneous 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, 2018.4. 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.
- 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.
- Co-registration tools available within IntraSight 7 configuration via SyncVision.
- Zhang J et al. The ULTIMATE trial. Journal of the American College of Cardiology (2018), doi.org/10.1016/j.jacc.2018.09.013.
- Patel M, et al., ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 8. 2018 ESC/EACTS Guidelines on myocardial revascularization: The task force on myocardial revascularization of the European society of cardiology (ESC) and European association for cardio-thoracic surgery (EACTS). Eur Heart J. 2018;00:1-96.
- Lofti A, et al. Focused update of expert consensus statement: Use of invasive assessments of coronary physiology and structure: A position statement of the society of cardiac angiography and interventions. Catheter Cardiovasc Interv. 2018;1–12.
- 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.
- Comparisons to Verrata Plus. Data/report internally on file or internal company’s data on file. Verification Report, D000410086/A.
- Data shown is in average, based on the comparison between remotely connected and non-remotely connected systems. Data sample from 2018 for Allura FD and Azurion (n=9955)
- Results obtained during a Usability Evaluation in the period of May and June 2019. The tests involved 23 clinicians (16 physicians and 7 technologists) from Europe who performed procedures using Azurion 2.1 image-guided therapy system in a cardiac workflow and non-cardiac workflow in a simulated interventional lab environment.