The FlowGuide is Rapid Exchange or so-called Monorail design. The FlowGuide has a distal shaft connected to a proximal shaft / push rod with a proximal end stop connected at the proximal end. The distal shaft is stainless-steel reinforced. The reinforced distal shaft ends in an integrated soft distal tip to facilitate advancement of the device through a guiding catheter and into the main coronary vessels. In addition, the outer surface of the distal shaft and tip are equipped with a hydrophilic coating and the inner surface with a silicon coating for increased lubricity. The distal shaft has a radiopaque distal tip that in conjunction with fluoroscopy, aids in the placement of the guide extension. The distal shaft of the FlowGuide has an additional radiopaque marker at the proximal end that in conjunction with fluoroscopy, aid in preventing distal shaft exit the guiding catheter. Furthermore, the FlowGuide has side holes in its distal shaft to allow blood flow through the side holes to distal vasculature to aid in reducing the risk of ischemia. The guide extension has two markers on the push rod that indicate approximately, the exit of the distal tip from the guiding catheter (brachial – 90 cm, femoral – 100 cm). The IMDS family of guide extensions will be used in guiding catheters of 90 and 100 cm length, supplied with accessories. The effective length of the guide extensions will be 150 cm. For FlowGuide, a flexible transition zone is present on the push rod as an additional aid for smooth entry of intravascular devices.
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.