Keep Your Finger on the Pulse: Q2 2024 Recap Newsletter

 

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Important Safety Information 

 

CORONARY ISI:

 

In the United States: Rx only

Indications for Use— The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and 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 and 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 nonemergency coronary artery bypass
surgery-Emergency or nonemergency 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/insuffciency-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.

In the US: Rx Only. Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings,
precautions and adverse events. www.shockwavemedical.com/IFU 

Please contact your local Shockwave representative for specific country availability.

 

 

PERIPHERAL ISI:

 

In the United States: Rx only.

 

Indications for Use— The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

 

 

Contraindications— Do not use if unable to pass 0.014" (M5, M5+, S4, E8) or 0.018" (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

 

 

Warnings— Only to be used by physicians who are familiar with interventional vascular procedures—Physicians must be trained prior to use of the

device—Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

 

Precautions— Use only the recommended balloon inflation medium—Appropriate anticoagulant therapy should be administered by the physician—

Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.

 

Adverse effects– Possible adverse effects consistent with standard angioplasty include–Access site complications–Allergy to contrast or blood

thinner–Arterial bypass surgery—Bleeding complications—Death—Fracture of guidewire or device—Hypertension/Hypotension—Infection/sepsis—

Placement of a stent—renal failure—Shock/pulmonary edema—target vessel stenosis or occlusion—Vascular complications. Risks unique to the

device and its use—Allergy to catheter material(s)— Device malfunction or failure—Excess heat at target site.

 

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

 

 

Please contact your local Shockwave representative for specific country availability.

 

 

REDUCER ISI:

 

Caution: In the United States, Reducer is an investigational device, limited by United States law to investigational use.

The Reducer is subject of Investigational testing and is being studied in the COSIRA-II trial in Canada.

The Reducer is commercially available in certain countries outside the U.S. and Canada. Please contact your local representative for specific
country availability.

In the US and Canada: Investigational Use Only. Prior to use, please reference the Instructions for Use for more information on warnings,
precautions and adverse events: ifu.neovasc.com