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SEISMIQ™ Intravascular Lithotripsy System
Reimbursement
- IVL overview
- Technical specifications
- Ordering information
- Clinical data
IVL overview
Intravascular lithotripsy (IVL) is a catheter‑based therapy designed to treat patients with calcified coronary artery disease or peripheral artery disease. IVL delivers acoustic pressure waves inside a balloon to fracture hardened calcium, restore vessel compliance, and enable effective lesion preparation prior to definitive therapy, such as treating with a stent.
SEISMIQ IVL overview
Laser‑based IVL takes traditional IVL a step further.
By using focused laser energy to generate acoustic pressure waves within the balloon, SEISMIQ is designed to deliver precise, consistent calcium modification—helping physicians prepare complex lesions with greater control while minimizing the need for high‑pressure dilation.
One Console. Two specialized therapies.
The SEISMIQ IVL platform is built around a shared console designed for both coronary and peripheral procedures. While the SEISMIQ™ 4CE Coronary IVL Catheter and SEISMIQ™ Peripheral IVL Catheter are engineered for different vessel anatomies and clinical needs, they connect to the same intuitive SEISMIQ console.
With a single console platform, SEISMIQ can support both coronary and peripheral calcium modification through familiar workflows, a common user interface, and the same laser-based IVL technology. Clinicians simply connect the appropriate SEISMIQ catheter for the intended procedure.
It’s time for a SEISMIQ shift in IVL.
Technical information
SEISMIQ console specifications
| Feature | |
|---|---|
| Built-in-test | Built-in-tests and monitors are designed to detect designated malfuntions of subsystems within the console. The console is designed to interrupt therapy delivery in the event a malfunction is detected. |
| Classification product | Class I Safety Medical Equipment per IEC 60601-1 |
| Classification applied parts | Type CF Defribrillation Proof |
| Data log | The console logs important software and hardware events for troubleshooting. No patient information is managed or recorded by the SEISMIQ IVL console. |
| Dimensions | Height: 1.5 m Width: 0.8 m Depth: 1.1 m |
| Environment | Operating Temperature: 15°C to 35°C Operating Relative Humidity: 15% to 70% non-condensing Storage Temperature: -30°C to 60°C Storage Relative Humidity: 15% to 90% Atmospheric Pressure: 794 mbar to 1013 mbar |
| Mobility | Product is designed to be movable |
| Power | 100–240 VAC 50/60 Hz |
| Relative pressure measurement | Measurement range: 0–30 ATM Measurement accuracy: ± 0.2 ATM |
| Splash resistance | Protected from condensation |
| Weight | 190 lbs or 85 kg |
| Fuses | 2 X T 10AH 250V |
SEISMIQ Intravascular Lithotripsy System is not yet approved or available for coronary, this is only available for peripheral.
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Ordering information for SEISMIQ™ Intravascular Lithotripsy System
Review the ordering detail information below. Contact a rep to order
SEISMIQ™ Intravascular Lithotripsy Console
| Description | UPN | GTIN |
|---|---|---|
| Console, Seismiq IVL North America | FG-010978 | 008850056723084 |
SEISMIQ™ Peripheral Intravascular Lithotripsy Catheters
| Description | Working Length | Guidewire (in) | UPN | GTIN |
|---|---|---|---|---|
| 3.5 mm x 60 mm | 145 cm | 0.014 | FG-006912 | 00850056723008 |
| 4.0 mm x 60 mm | 145 cm | 0.014 | FG-006913 | 00850056723015 |
| 5.0 mm x 60 mm | 145 cm | 0.014 | FG-006915 | 00850056723039 |
| 6.0 mm x 60 mm | 145 cm | 0.014 | FG-006917 | 00850056723053 |
| 7.0 mm x 60 mm | 145 cm | 0.014 | FG-006919 | 00850056723077 |
| 8.0 mm x 60 mm | 145 cm | 0.014 | FG-006921 | 00850056723091 |
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*CAUTION: For coronary procedures this is an investigational device limited by US law to investigational use only. Only currently available for sale for use in peripheral procedures.
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