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The PV 2000 Synchro®2 Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PV 2000 is a member of the Synchro® Guidewire family of products having a 0.014" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer/shaping mandrel (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm length. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

The PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for peripheral and neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PV 1900 is a member of the Synchro® Guidewire family of products having a 0.016" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Boston Scientific (K903606)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. A traditional range of flexibility profiles shall also be provided ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

The "PivotTM" Steerable Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.017". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.