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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from arterial blood vessels within the body. The FreedomFlow™ Orbital Circumferential Atherectomy System is used together with a compatible introducer sheath and 0.014-inch diameter x 300 cm (minimum length) atherectomy guidewire. The driveshaft is introduced into the patient's vasculature by traditional minimally invasive techniques. The FreedomFlow™ User Handle is available in model numbers that are listed below with vessel size ranges. The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) includes an integrated driveshaft with multiple abrasive spheres on a rotating driveshaft. The abrasive spheres are eccentrically mounted onto the driveshaft so that when the driveshaft is rotated, they move outward due to centrifugal force. These abrasive spheres are spaced along the driveshaft in a spiral configuration to optimize plaque modification within a vessel while still maintaining flexibility for treating tortuous arterial anatomy. The User Handle includes two rotational speeds: low speed at 50,000 revolutions per minute (RPM) and high speed at 76,000 RPM. The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) is powered by Cardio Flow Power Supply H7001, which is a hospital-grade portable, reusable component. H7001 provides DC power to rotate the FreedomFlow™ driveshaft. H7001 also provides DC power to a saline pump integrated into the FreedomFlow™ User Handle. During operation the saline pump delivers saline to the distal tip of the driveshaft. The FreedomFlow™ orbital atherectomy User Handle is supplied single patient use, sterile. The package contents include the following items. - FreedomFlow™ orbital atherectomy User Handle with integrated electric motor and saline pump - Saline infusion tubing set

The Turbo-Elite devices are indicated for use in treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014" and 0.018" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Turbo-Elite laser atherectomy catheters are percutaneous intravascular devices constructed of multiple optical fibers in a concentric array around a guidewire lumen. The optical fibers are enclosed in an outer jacket and the working length of the device is coated with a hydrophilic coating. The distal tip of the catheter includes a Platinum Iridium outer Marker Band which is visible under fluoroscopy. The proximal end consists of a tail tube and a coupler which connects the device to the CVX-300 or PLS laser systems. Turbo-Elite is designed and intended to be used exclusively with Spectranetics' CVX-300 Excimer Laser System and Philips Laser System (PLS). The catheters transmit ultraviolet energy from the laser system to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue. During a laser atherectomy, and under fluoroscopic guidance, a physician advances the introducer sheath to the target lesions. The Turbo-Elite catheters are then advanced to the proximal end of the lesion to be treated.

The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied quidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip.

The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as a therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inquinal arteries. The Auryon ™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inquinal stenoses and occlusions.

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 mJ/mm2 to the occluded or narrowed artery. The laser delivers very short high intensity pulses which travel from the laser, through the fibers, and emerge from the polished ends of the individual fibers. As the UV light emerges from the fiber end, it will be absorbed by the fluid, and create a cavitation bubble within the fluid. The collapse of this bubble results in a photoacoustic shockwave that disintegrates rigid materials such as calcified lesions without relying on thermal degradation to break down the stenotic material. The Auryon™ Atherectomy System must work over a commercially available guide wire that crosses the lesion intra-luminally. The catheters are available in seven configurations (0.9mm, 0.9mm, 1.5mm, 1.5mm XL, 1.7mm, 2.0mm and 2.35mm), with and without hydrophilic coating. For the small size catheters (i.e., 0.9mm.1.5mm, and 1.7mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm, 1.5mm, and 1.7mm catheters do not have an aspiration feature and have not been tested in ISR lesions. The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only. The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions. The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.

The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy System must work over a commercially available 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in six configurations (0.9mm, 0.9mm XL, 1.5mm, 1.5mm XL, 2.0mm and 2.35mm), with and without hydrophilic coating. For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions. The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions. The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter. The modification associated with this submission is to add a second catheter length (225cm) for the size 0.9 and 1.5 mm catheter sizes. The ID of the 0.9mm catheter is also increased slightly. There are no changes to the Auryon Laser Console unit associated with this submission.

The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. Both 5 Fr and 6 Fr variations of the User Handle are available. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy System must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm), with and without hydrophilic coating. For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions. The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions. The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter. The modification associated with this submission is to add a platinum/iridium marker band within the wall of the 0.9 mm coated and uncoated catheters adjacent to the existing stainless steel inner blade. This marker band will enhance the radiographic contrast of the device. There are no changes to the Auryon Laser Console unit associated with this submission.

The Pantheris LV System is indicated to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris LV catheter combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris LV System consists of the Pantheris LV catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Pantheris LV catheter is a 7 French device with a working length of 110 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Pantheris LV catheter incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox.