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The TightRail Mechanical Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.

The TightRail Mechanical Dilator Sheaths are mechanical, intra-operative devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an outer support sheath. The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the catheter. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail is 47.5 cm.

The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The Turbo-Elite Atherectomy Catheter is a laser atherectomy catheter constructed of multiple optical fibers arranged circumferentially around a guidewire lumen (0.014 and 0.018, presently). Turbo Elite Laser Catheters are available in Over the Wire (OTW) and Rapid Exchange (RX) configurations. The proposed catalog additions are over-the-wire (OTW) 0.035" guidewire compatible with crossing profiles of 2.3mm and 2.5mm. The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing. The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.

The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandem® System (Laser Guide Catheter with Laser Atherectomy Catheter) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectorny catheter. Specifically, the guiding catheter portion of the Turbo-Tandem® System includes an angled biasing tip to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The incorporated laser catheter of Turbo-Tandem® System is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) guidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter has a radiopaque marker bands at the distal tip. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing. The guiding catheter portion of the Turbo-Tandem® System is comprised of a handle with an incorporated flush port, a braided shaft with hydrophilic coating, and a biasing tip with two radiopaque marker bands. The handle features a six-position locking mechanism to position the laser catheter on the ramp of the biasing tip. The Turbo-Tandem® System is provided sterile and is intended to be single-use.

Indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandem™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser atherectorny catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The Turbo-Tandem System is designed to directionally ablate infrainguinal concentric and eccentric lesions in vessels 5mm or greater at or above the knee. The Turbo-Tandem System is not designed to be used in total or sub-total occlusions. In the event of a total or sub-total occlusion a pilot channel is recommended. The guiding catheter portion of the Turbo-Tandem™ System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem™ System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) quidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing catheter portion of the Turbo-Tandem™ System is comprised of a handle with an incorporated flush port, proximal coupler, tail tubing, strain relief tubing, braided shaft with a hydrophilic coating, two radiopaque marker bands in the distal tip with a platform, and one radiopaque marker band at the distal end of the laser catheter.

The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

The VisiSheath™ Dilator Sheath is a single lumen polymer sheath used independently or as a support for an inner sheath to facilitate tissue dilation. One end is terminated with a 45° angle cut, while the other end is blunt. Both ends contain a metallic radiopaque marker band to enable fluoroscopic identification of tip location and orientation. An additional exterior mark aligned with the tip of the 45° angle cut permits visual identification of sheath orientation. There are multiple diameter and length options available.

Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These catheters are available in a variety of lengths, diameters and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating on the distal 100cm for catheters with a working length greater than 100cm and 60cm for those with a working length less than 100cm

Indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandern™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser ablation catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The guiding catheter portion of the Turbo-Tandem System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a guidewire lumen and has a fiber optic surface area similar to a 2.0mm laser catheter.

Cross-Pilot" Turbo elite Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.

The Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters are intravascular catheters. These catheters are available in a variety of lengths and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating.

Cross-Pilot™ Turbo Elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating. Predicate devices of this type with similar intended uses have been classified into Class II. The support catheters are single-use and provided in sterile packaging.