The Halifax Imaging Kit is part of the SR Suite product line, provides an altern
The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability.
The IVL Catheter is a proprietary lithotripsy device delivered through the perip
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 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 IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. 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 proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.
Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
The IVL Catheter is a proprietary lithotripsy device delivered through the perip
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 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 IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. 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 proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.
Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
The IVL Catheter is a proprietary lithotripsy device delivered through the perip
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 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 IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. 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 proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.
Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
The IVL Catheter is a proprietary lithotripsy device delivered through the perip
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 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 IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. 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 proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.
Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+