(60 days)
The Shockwave Medical IVL System with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries, prior to final treatment.
Not for use in the coronary, carotid, cerebral, or pulmonary vasculature.
The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing dilation of peripheral artery stenosis.
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is racilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses.
The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile.
The IVL Generator and Connector Cable are used with the Shockwave Javelin Peripheral IVL Catheter to deliver localized, lithotripsy-enabled modification and crossing of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal - PG) | Reported Device Performance | Achieved? |
|---|---|---|
| Primary Safety Endpoint: 30-Day MAE rate ≤ 11.2% | 1.1% (1/90) with upper 95% Confidence Limit of 6.0% | Yes (p=0.0012) |
| Primary Effectiveness Endpoint: Technical Success (final residual stenosis ≤50% without flow-limiting dissection ≥ Grade D) ≥ 85.0% | 99.0% (97/98) with lower 95% Confidence Limit of 94.4% | Yes (p Grade D) |
| Post-Javelin mean residual stenosis | 59.1 ± 18.4% | |
| Post-Javelin residual stenosis ≤ 50% | 36.5% (31/85) | |
| Post-Javelin residual stenosis ≤ 30% | 3.5% (3/85) | |
| Post-dilatation mean residual stenosis | 31.3 ± 13.7% | |
| Post-dilatation residual stenosis ≤ 50% | 93.8% (91/97) | |
| Post-dilatation residual stenosis ≤ 30% | 50.5% (49/97) | |
| Final mean residual stenosis | 23.0 ± 9.1% | |
| Final residual stenosis |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).