Deficiencies of current FFR technologies

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• Clinical advantage of FFR was proved by existing systems that are currently on the market

• However Those products are suffering from technological backbones that prevents FFR from being widely used in the Cath-labs as many expert cardiologist want.

Deficiencies includes:

• Accuracy and low stability (drift) problems:

• Risk for VF + Adenosine side effects Insufficient guide wire performance:

• Not suitable for stenting procedure in many cases Extremely high cost

• Repeated measurements are required in many cases • time consuming,

• More X-way and contrast media exposure. • Induction of Adenosine is mandatory

• $500 to $1000 per disposable unit
• Expansive Capital equipment is needed for the display and monitoring systems

• CardioSert technology is to overcome this obstacles in order to provide much more applicable product to the market.

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The CardioSert Technology

A pressure guide wire that is a 0.014” compatible, comprising a handle with an integrated display to show the pressure readings or means to wirelessly transferring data to a monitor. The pressure guide wire is hollow, and it is hydraulically connected to handle, which contains a pressure sensor. The handle is removable and detachable from the hollow guide wire thus enabling delivery of catheters, deployment of stents or delivery of a medication through the wire.

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CardioSert Product

• CardioSert product is able to measure the blood pressure in the coronary artery distal to the stenosis blockage; compare this Distal Pressure with the blood pressure in the aorta (Aortic Pressure) and accurately calculate the index of FFR.

• FFR is an index of the severity of a coronary stenosis blockage.

• FFR is an impotent decision making tool. FFR provides the interventional cardiologist physician a reliable and accurate way to decide if stenting procedure is required or not.

• Experts believe that FFR can lower the number of interventions – Resulting inbetter improved patient health whilst reducing costs

• Various clinical studies demonstrate that stenosis blockage assessment by FFR to guide stenting procedures is superior to current angiography (X-way Imaging) guided treatment.

• In case that stenting is required, CardioSert product is used as a deliver system (Guide Wire) for introducing the balloon/stent catheter to the stenosis blockage.

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Advantages of CardioSert new technology

CardioSert Hydraulic FFR Guide Wire

•  Stable and high accuracy FFR measurements

•  Seamlessly integrated with PCI catheterization procedures

•  Functionality & properties of standard balloon/stent delivery guide wires

•  Low production costs

•  No capital equipment

•  Easy and Convenient Operation

•  Integrated with the PCI procedure flow

•  Allow checking of the stenting outcomes in-site without changing a wire

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Convenient Priming Procedure

• Guide is packed in separate from the pressure sensor

• Guide Wire is delivered in a sterile, dry condition

• Before inserting the FFR guidewire to the patient the operator fills the hollow lumen of the guidewire with a sterile water-based solution (i.e. Heparin or Saline).

• This step (known as “Prime”) is done by injecting the solution to the lumen through the removable port until drops of the solution expressed out of the distal end of the FFR guidewire Results

• Convenient procedure

•  Procedure is done off-the-shelf equipment

• Pressure sensor is safe from the high pressures developed during the priming procedure