ivl uses sonic pressure waves to crack calcium in situ...ivl uses sonic pressure waves to crack...

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IVL Generator IVL Connector Cable MINIMIZE TRAUMA Minimize trauma to soft tissue by safely selecting and fracturing intimal and medial calcium OPTIMIZE OUTCOMES Optimize stent delivery, expansion and apposition while reducing complications and cost escalation SIMPLIFY PROCEDURES Simple and intuitive system that makes complex calcified coronary procedures more predictable Coronary Intravascular Lithotripsy (IVL) System YOUR SOUND CALCIUM STRATEGY. IVL Uses Sonic Pressure Waves To Crack Calcium In Situ With the integrated balloon expanded to 4-atm by a mixed saline and contrast solution, a small electrical discharge at the emitters vaporizes the fluid and creates a rapidly expanding bubble within the balloon that collapses quickly to create sonic pressure waves. The acoustic pressure waves travel through the fluid-filled balloon and pass through soft vascular tissue, selectively cracking the hardened calcified plaque at ~50 atm. The emitters along the length of the balloon create a localized field effect within the vessel to fracture both intimal and medial calcium. The integrated balloon plays a unique role unlike traditional angioplasty balloons; its apposition to the vessel wall serves its primary purpose to facilitate efficient energy transfer during IVL, after which, it can then also be used to dilate the lesion to maximize lumen gain with the IVL catheter. IVL Case Reports: Simplifying the Most Complex Calcified Scenarios Multi- Vessel Disease Pre-IVL Post-Stent Lithotripsy Emitters IVL Catheter Proximal & Diffuse Disease Acute Angulation & Tortuous Anatomy High-grade Calcified Stenosis Pre-IVL Post-Stent

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Page 1: IVL Uses Sonic Pressure Waves To Crack Calcium In Situ...IVL Uses Sonic Pressure Waves To Crack Calcium In Situ With the integrated balloon expanded to 4-atm by a mixed saline and

IVL Generator

IVL ConnectorCable

MINIMIZE TRAUMAMinimize trauma to soft tissue by safely selecting and fracturing intimal and medial calcium

OPTIMIZE OUTCOMESOptimize stent delivery, expansion and apposition while reducing complications and cost escalation

SIMPLIFY PROCEDURESSimple and intuitive system that makes complex calcified coronary procedures more predictable

Coronary Intravascular Lithotripsy (IVL) System YOUR SOUND CALCIUM STRATEGY.

IVL Uses Sonic Pressure Waves To Crack Calcium In Situ

With the integrated balloon expanded to 4-atm by a mixed saline and contrast solution, a small electrical discharge at the emitters vaporizes the fluid and creates a rapidly expanding bubble within the balloon that collapses quickly to create sonic pressure waves.

The acoustic pressure waves travel through the fluid-filled balloon and pass through soft vascular tissue, selectively cracking the hardened calcified plaque at ~50 atm. The emitters along the length of the balloon create a localized field effect within the vessel to fracture both intimal and medial calcium.

The integrated balloon plays a unique role unlike traditional angioplasty balloons; its apposition to the vessel wall serves its primary purpose to facilitate efficient energy transfer during IVL, after which, it can then also be used to dilate the lesion to maximize lumen gain with the IVL catheter.

IVL Case Reports: Simplifying the Most Complex Calcified Scenarios

Multi-Vessel

Disease

Pre-IVL Post-Stent

Lithotripsy Emitters

IVL Catheter

Proximal & Diffuse Disease

Acute Angulation & Tortuous

Anatomy

High-grade Calcified Stenosis

Pre-IVL Post-Stent

Page 2: IVL Uses Sonic Pressure Waves To Crack Calcium In Situ...IVL Uses Sonic Pressure Waves To Crack Calcium In Situ With the integrated balloon expanded to 4-atm by a mixed saline and

Visit shockwavec2.com or email [email protected] for more information.

For Use Outside the U.S. Only.Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. Contact Shockwave Medical at [email protected].© 2018 Shockwave Medical Inc. All rights reserved. SPL 61785  Rev. D

Length 5 ft (1.53m)

Compatibility Connector Cable has a male key designed on the proximal designed to connect to the Catheter.

Operation Lithotripsy pulsing is activated by pushing a button on the Connector Cable.

Connector Cable Use Re-usable

CATALOG NUMBER DIAMETER (mm)

LENGTH (mm)

GUIDEWIRE COMPATIBILITY

GUIDE CATHCOMPATIBILITY

WORKING LENGTH

PULSES (max)

C2IVL2512 2.5 12 0.014" 6F 138 80

C2IVL2812 2.75 12 0.014" 6F 138 80

C2IVL3012 3.0 12 0.014" 6F 138 80

C2IVL3312 3.25 12 0.014" 6F 138 80

C2IVL3512 3.5 12 0.014" 6F 138 80

C2IVL3812 3.75 12 0.014" 6F 138 80

C2IVL4012 4.0 12 0.014" 6F 138 80

Power 110-240 VAC; 50-60Hz; Single Phase, 15A service

Size 11" (28.0 cm) high x 6" (15.2 cm) wide x 11.5" (29.2 cm) deep

Weight 15 pounds (6.8 kg)

Output Proprietary pulse delivery system. Output voltage 3000 voltspeak, pulse frequency 1Hz

Mobility

Product is designed to be mounted to a stable mobile or stationary IV pole. An IV pole with five casters located in a circular pattern with a diameter of at least 23 inches (58 cm), such as the I.V. League Ventilator Stat-Stand™ model 1059 (or equivalent) is recommended.

IVL CATHETER SPECS

IVL GENERATOR AND CONNECTOR CABLE SPECS

IVL Connector Cable

CATALOG NUMBER:IVLCC

IVL Generator

CATALOG NUMBER:IVLGCC

Compelling Performance in DISRUPT CAD I¹

2.1mm2 5.9mm2

Outcomes Results

30-Day Freedom from MACE2

Death N=0; QWMI N=0; NQWMI³ N=3; TVR N=0

95%

Dissections4 (D/E/F) 3.3%5/0.0%/0.0%

Perforation4 0%

Abrupt Closure4 0%

Slow flow4 0%

No reflow4 0%

Stent Delivery 100%

1CAD I assessed the safety and performance of IVL in 60 subjects across 7 sites with moderate/severely calcified, de novo coronary lesions RVD 2.5–4.0 mm, stenosis ≥50%, lesion length ≤ 32 mm.²CEC adjudicated³NQMI defined as 3 upper limit4Core Lab adjudicated53.3% resolved with planned stent implantation

A. Calcified, stenotic lesion

Treat with IVL

B. Large luminal gain with multiple calcium

fractures (white arrows)

Deploy Stent

C. Stent expansion showing compliance

and increased fracture size with additional

increase in acute gain

Frames are co-registered to ensure cross-sections are in the same location

100% of pts had mod/sev CACAcute Area Gain Post-IVL

Mean Stent Area

Max. Tip Profile = 0.023-in (0.584-mm) ± 0.001-inMax. Crossing Profile = 0.042-in (1.07-mm) ± 0.001-in