Search Results

The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

The SCIMED® Informer™ Pressure Wire System consists of the following components: - · a guide wire, - · a disposable transducer with attached cable, and - · a permanent cable. The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters. The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.

SCIMED 6 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

The shaft of the 6 F Wiseguide guide catheter utilizes biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity. In addition, the outer primary catheter shaft is constructed of various material durometers providing transitional flexibility to the distal curve area of the catheter. The catheter is radiopaque to allow visualization under fluoroscopy during a procedure. The devices will be provided sterile and are intended for one procedure use only.

The SCIMED Quest Floppy and Moderate Support Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The Quest Floppy and Moderate Support Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Quest Floppy and Moderate Support Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy and Moderate Support. The distal two centimeters of both models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip.

The SCIMED 6 French IMPULSE™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models. The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure. A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.

SCIMED 7 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

The shaft of the 7 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity. In addition, the outer primary catheter shaft is constructed of various material durometers providing a distal curve area of the catheter with transitional flexibility. The distal tip is radiopaque to allow visualization under fluoroscopy during a procedure. The devices will be provided sterile and are intended for one procedure use only.

The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).

SCIMED guide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature

The shaft of the 8 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner polytetrafluoroethylene (PTFE) layer that provides a low coefficient of friction and facilitates easy passage of medical devices such as balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer which is made of braided stainless steel wire that extends from the shaft to the tip to provide kink resistance, torque control and support and 3) the outer layer, manufactured from Pebax® and a radiopaque filler, which provides stiffness, memory and radiopacity. In addition, the distal 5.8 to 17.5 inches (depending on the curve style) of the outer primary catheter shaft is constructed of multiple sections of Pebax. These sections are composed of durometers of Pebax providing a distal curve area of the catheter with transitional flexibility. The catheter is assembled as components over a core mandrel. The catheter shaft is then heat fused, forming a composite catheter shaft. This process results in a continuous inner and middle layer and a seamless outer shaft layer. The distal tip is made of Pebax and is radiopaque to allow visualization under fluoroscopy during a procedure. The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The 8 F Wiseguide Guide Catheters have a 0.086" ID. The catheters will be available in lengths ranging from 40 to 125 cm, with optional side holes. The devices will be provided sterile and are intended for one procedure use only.

The SCIMED ChoICE Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wire family is not intended for use in the cerebral vasculature.

The ChoICE Super Support and Super Support II Guide Wire models are steerable guide wires available in a nominal diameter of 0.014" and two tip configurations, straight shapeable and pre-formed J-Tip. A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the Super Support and Super Support II Guide Wire will be: ChoICE -190 cm, ChoICE Plus-182 cm, and ChoICE Exchange-300 centimeters.

The SCIMED ChoICE Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The ChoICE Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The available tip flexibilities are - · Floppy, - · Intermediate, - · Extra Support, - · Standard, - · Super Support, and - · Super Support II A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the guide wires are • ChoICE-190 cm, • ChoICE Plus-182 cm, and • ChoICE Exchange-300 centimeters.

The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The proximal section of the guide wire consists of a differential magnetic (Hiperco®) core wire encased in a FEP or PTFE coated stainless steel hypotube. The Hiperco® core wire/hypotube assembly is attached to the distal stainless steel core wire assembly by means of a weld and an adhesive bond. There are no other changes being made to the proximal section of the guide wires.