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The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the Guidant 1000 Series Microwave Generator. The Ablation Probe is an intraoperative, sterile, single-use, hand-held device that applies microwave energy to tissue. The Ablation Probe is comprised of a 24-cm-long, rigid handle with position indicators, a metallic shaft, a proximal control tube, a flexible sheath featuring black numbered markings together with right and left hand side markings, a detachable distal control tube, and a guide lead with sutures. The Ablation Probe further includes a 2-m-long insulated coaxial cable, which attaches to the generator output cable connector. The Microwave Generator's output (2450 MHz) is conducted through the output cable connector, into the cabling of the Ablation Probe, and out the antenna at the distal section of the Ablation Probe. The emitted microwave energy is directed toward the target tissue from the active surface opposite the corresponding numbered marking (segment), and creates a continuous lesion approximately 26 mm long. The black side-markings indicate the sides of the sheath. The numbered markings designate each numbered segment of the sheath and correspond to the position indicators on the handle. The ablations are created by independently activating the microwave ablation element at one or more of the corresponding numbered segments, which are selected by moving the sliding ring on the handle.

The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-loaded polyurethanc on the distal portion and polytetrafluoroethylenc (PTFE) on the proximal portion of the wire. The polyurethane is covered with a hydrophilic coating to increase lubricity. The guide wire is 190 cm long with a maximum outer diameter of 0.0145. The guide wires are available with cither a straight distal tip that is shapeable, or a preformed 'J' distal tip shaped specifically for accessing the coronary sinus.

The RX ACCUNET™ 2 Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the portery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The RX ACCUNET™ 2 Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System and a second-generation RX ACCUNET™ 2 Recovery Catheter. The RX ACCUNET™ 2 Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy

The ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The ACCUNET™ Embolic Protection System is an over-the-wire, filtration-type, embolic protection device, filtering distal to the interventional site. The ACCUNET™ System is delivered via a Delivery System, utilizing a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once the Guide Wire is across the lesion, the Filter Basket is expanded in the artery lumen by removing the Delivery Sheath. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery System, retaining any potential embolic collected during the procedure. The system and any captured embolic particles are then removed through the guiding catheter or sheath. Like the ACCUNET™ Embolic Protection System, the RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The RX ACCUNET™ System is delivered in a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by advancing the Filter Basket from the Delivery Sheath from the Guide Wire using the torque device. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit.

The OMNILINK® .018 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree. The OMNILINKR® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .018 Biliary Stent System is comprised of a stainless steel, balloonexpandable stent pre-mounted onto an over-the-wire (OTW) delivery catheter. This system is designed for percutaneous placement in the common bile duct and intended to treat malignant strictures in the biliary tree. The OMNILINK® Biliary Stent consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The delivery catheter's central lumen is designed to permit the use of a 0.018" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent prositioning. The stent is designed to remain in the biliary duct as a permanent implant. The subject OMNILINK® .018 Biliary Stent System consists of additional stent sizes of 110 5.0, 6.0, 7.0mm stent diameter, 12 and 16mm stent lengths, and 4.0mm stent diameter x 18mm stent length. The stent and delivery system are supplied sterile and intended for single use only.

The ABSOLUTE™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

The ABSOLUTE™ Biliary Self-Expanding Stent System is comprised of the ABSOLUTE™ stent pre-mounted on an over-the-wire delivery system. The delivery catheter consists of three coaxial members (an inner member, a retractable outer member, and an outer, outer member), a guide wire lumen, a distal soft tip and a proximal handle with retraction and locking features. The distal section of the outer member constrains the stent on the inner member. Deployment of the ABSOLUTE™ stent occurs when the outer member is retracted by activating the retraction features in the handle.

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.

The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.

The Cutter is an accessory manufactured for use with the RAPIDO Cut-Away Guiding Catheter, for the treatment of Congestive Heart Failure. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. This new removal process is necessitated by the larger IS-1 terminal pin that future leads will incorporate. The Cutter currently has only one manufacturing configuration. The Cutter consists of three sections; A handle, a stainless steel blade and a lead management section. The lead management section stabilizes the lead, prior to, and during the cutting procedure. After the lead has been fixed in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the doctor pulls the catheter against the cutter blade. The hub is cut first and then the catheter section.

The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the IS-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.

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The Guidant Vaso View® Endoscopic Vessel harvesting system is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for patients requiring blunt dissection of tissue including dissection of blood vessels, separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissection along the saphenous vein or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.

The VasoView System is made up of 6 components including: - 1) Blunt Tip Trocar (BTT) with Syringe, - 2) 5 mm Extended Length Endoscope, - 3) Uniport Plus Dissection Cannula, - 4) VasoView Dissection Cannula, - 5) Uniport BiSector and - 6) Uniport Bipolar Scissors. These are the exact same devices used for saphenous vein harvesting and have been previously cleared by FDA. Each device is described below. BTT: The BTT is a single use device provided sterile. The BTT is used to provide a port of access for insertion of endoscopic instruments into an incision site. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converters to allow insertion of instruments of different diameters than the main seal and an external one-way valve for gas insufflation. To minimize leakage and secure the port, the distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon. 5mm Extended Length Endoscope: The 5mm Extended Length Endoscope is a multi-use product supplied non-sterile and must be cleaned and sterilized prior to use. The device is used to visualize endoscopic cavities. It consists of a stainless steel shaft containing optics. The proximal end has an eyepiece, for camera attachment, and a light cable post for light cable connection. Uniport Plus Dissection Cannula The Uniport Plus Dissection Cannula is a single use device provided sterile. The Uniport Plus Dissection Cannula is designed to be used in conjunction with the 5mm Extended Length Endoscope. The cannula has a removable conical tip and four lumens to house the endoscopes, vessel cradle/distal lens washer and bipolar instrument for ligation and division of vessel branches. The vessel cradle/distal lens washer is independently controlled by a slider button on the handle of the device for retraction and blunt dissection of tissue as well as washing of the distal tip of the scope. The bipolar instrument is inserted independently into the cannula and can be controlled at the proximal end for blunt dissection. Dissection System: The Dissection System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tunneling, which separates tissue planes, forming a cavity. The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear for endoscopic visualization during tunneling. An elliptical bulb aid tissue separation. A handle is provided to assist with advancement of the cannula. Uniport BiSector: The Uniport BiSector is a single use device provided sterile. The Uniport BiSector is a 5mm flexible endoscopic ligating forcep and is intended to be used with the Uniport Dissection Cannula. Bipolar coagulation is achieved using electro surgical energy under endoscopic visualization. Transection is achieved through mechanical actuation of the slide button. This device is intended to be used with the bipolar outputs of compatible generators. Bipolar Scissors: The Bipolar Scissors are a single use device provided sterile. The Bipolar Scissors are 5mm cutting and bipolar coagulation scissors and are intended to be used with the Dissection Cannulas. Mechanical cutting and bipolar coagulation is achieved using electrosurgical energy under endoscopic visualization. This device is intended to be used with the bipolar outputs of compatible generators.