TCT21 IVL Lineup

This year at TCT 2021, we’re pulling out all the stops. With inpatient and outpatient reimbursement now in place, we’ve delved deeper into the current coronary IVL clinical evidence to get data-driven answers for some of your most pressing questions:

 

Q: What will longer term coronary data look like?
A: Hear the first 1-year outcomes with coronary IVL from the Disrupt CAD III study presented by Dr. Jonathan Hill in the featured clinical research session.

 

Q: How does IVL perform in concentric vs. eccentric vs. nodular calcium?
A: Check out the Disrupt CAD Pooled OCT analysis – the largest imaging analysis of any calcium tool – presented by Drs. Ziad Ali and Akiko Maehara in the moderated posters and Shockwave symposium.

 

Q: Is it necessary to document fracture post-IVL?
A: See the visible fracture vs. non-visible fracture analysis from the Disrupt CAD Pooled OCT analysis in the moderated posters, and hear about the new research from Dr. Renu Virmani in the moderated posters.

 

Q: Will females have poorer clinical outcomes like other calcium tools?
A: Tune in for the first male vs. female analysis in the Disrupt CAD Pooled data set by Dr. Alexandra Lansky in the moderated posters and Shockwave symposium.

 

Have more questions? Shockwave is hosting three days of “Meet the Experts” sessions in the Shockwave booth for insights and discussion with leading calcium masters – you won’t want to miss it.

 

Pre-TCT 2021 Flyer_Oct8

 

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For real-time data results and updates from TCT21, follow @ShockwaveIVL on Twitter.

 

 

 

Important Safety Information

 

Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 instructions for use containing important safety information.

 

Rx only

 

Indications for Use—The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

 

Contraindications—The Shockwave C2 Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

 

Warnings— Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE.  Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure.  IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required.  In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

 

Precautions— Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

 

Potential adverse effects consistent with standard based cardiac interventions include– Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or non-emergency coronary artery bypass surgery-Emergency or non-emergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)-Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke-Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.

 

Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture.

 

Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events.  https://shockwavemedical.com/IFU

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