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

The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis. The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer. The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.

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.

The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral 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. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral 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. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave E Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

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 ilia-femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral 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. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen. and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood. The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are nonsterile reusable devices.

The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral 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. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave Mr+ Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized. lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator. IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

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

The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood. The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral arterv stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are non-sterile reusable devices.

The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood. The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are non-sterile reusable devices.

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, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical IVL System has three components: a proprietary balloon Catheter, a Generator, and a Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood. The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and Connector Cable are non-sterile reusable devices.