SCAI 2022: New Practice-Changing IVL Data
In a few weeks, we are headed to a city known for its sunshine and southern hospitality, Atlanta, Georgia, where SCAI 2022 is taking place this year. At the conference, leading calcium experts will share the 1-year results from the Randomized Disrupt PAD III Trial and 1-year sex specific outcomes with Coronary IVL.
Peripheral IVL at SCAI
If you are attending SCAI 2022, don’t miss Dr. William Gray present the highly anticipated 1yr outcomes of the Disrupt PAD III Randomized Trial. Dr. Gray kicks off the Featured Clinical Research Session at 8:20am on Thursday, May 19th. The IVL momentum continues the first day of SCAI – at 11:30 join Shockwave and an expert panel (Dr. Sahil Parikh, Dr. William Gray, Dr. John D. Corl and Dr. Peter Soukas) to understand the latest data, hear about the new Shockwave M5+ catheter and learn how IVL can fit into your treatment strategy for calcified PAD.
LATE BREAKING NEWS AND EVIDENCE FOR IVL
Thursday 19 May – 11:15 AM-12:15 PM EST | Regency VII Ballroom Level (LL1)
IVL for Peripheral Artery Calcification: 1-year Outcomes from the Randomized Disrupt PAD III Trial
Thursday 19 May – 8:20-8:30 AM EST | Centennial I Ballroom Level (LL1)
Coronary IVL at SCAI
Cardiovascular disease in women remains understudied, under-recognized, under-diagnosed, and under-treated. At SCAI 2022, join the Shockwave lunch symposium on Saturday, May 21 (12:30 pm - 1:30 pm) to learn more from a female panel who will discuss gender disparities in PCI outcomes and why coronary IVL is a potential first-line therapy for females with calcified lesions as evidenced in acute OCT outcomes and sustained long-term clinical benefits in both women and men.
Can’t attend the symposium? Both the Largest-long-term gender analysis of Coronary IVL DISRUPT CAD Pooled Gender Analysis: 1yr Outcomes and the Disrupt CAD Pooled OCT Analysis: Gender Characteristics by Gender will be presented separately on Saturday, May 21.
HOW IT STARTED VS HOW IT'S GOING: CORONARY CALCIUM MODIFICATION OUTCOMES IN MEN VS WOMEN
Saturday 21 May – 12:30-1:30 PM EST | Regency VII Ballroom Level (LL1)
Sex-specific OCT characterization of IVL treatment of calcified coronary lesions: Patient-level pooled analysis of the Disrupt CAD OCT sub-studies
Saturday 21 May – 12:00-12:30 PM EST | Grand Hall Foyer, Exhibit Level - LL2 (D-8)
Sex-specific 1-year outcomes in coronary IVL for treatment of severely calcified coronary lesions: A patient-level pooled analysis of the Disrupt CAD III and CAD IV studies
Saturday 21 May – 1:30-2:00 PM EST | Grand Hall Foyer, Exhibit Level - LL2 (E-19)
Let’s crack some calcium at SCAI 2022!
To keep up on the real-time Shockwave IVL activities at SCAI 2022, follow @ShockwaveIVL on Twitter!
Important Safety Information
Coronary Important Safety Information:
In the United States: 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
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 instructions for use containing important safety information.
Peripheral Important Safety Information:
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 or cerebral vasculature.
Contraindications—Do not use if unable to pass 0.014 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
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave S4, Shockwave M5, and Shockwave M5+ instructions for use containing important safety information.