Solving critical challenges in interventional cardiology
CardioSert has developed a revolutionary technology to provide the interventional cardiologist physician a reliable and accurate way to decide if stenting procedure is required or not.
CardioSert has developed 2 different active guide-wire product applications for angioplasty procedures. 1) a novel Crossing Guide Wire for revascularization of Chronic Total Occlusion (CTO) coronary and peripheral arteries & 2) a working horse guide-wire with Fractional Flow Reserve (FFR) measuring capabilities for use before & after a procedure. The Crossing Guide Wire has unique features such as producing elevated tapping impact on the calcified lesion for ultimate CTO penetration. The FFR guide wire saves a substantial amount of time, improves measurements, reduces insertions to just once & has no need for any injected Adenosine drug used with the existing FFR devices to improve their accuracy. And all at a substantial reduction in cost price.
Deficiencies of current FFR technologies
• 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.
• 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.
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.
• 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.
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
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
Procedure is done off-the-shelf equipment
• Pressure sensor is safe from the high pressures developed during the priming procedure
MARKET of FFR systems
• Global market valued at 530 million US$ in 2017
• Forecast to reach 1190 million US$ by the end of 2025
• Forecast to grow at a CAGR of 10.6% during 2018-2025.https://www.persistencemarketresearch.com/mediarelease/pressure- guidewires-market.asp
• The ASP (Average Selling Price) of existing FFR wire varies between $500 and$1,000.
• Significant growth is expected from finally meeting the unmet need of cardiologists; increasing the use of FFR in PCI, TAVI and other interventional and diagnostic procedures; expending the FFR use into new indications and market segments such as peripheral vascular procedures.
• The business space of the FFR guidewires is very active:
In 2015 Volcano was acquired by Philips for about $1B.
In 2017 Abbott Laboratories acquired St. Jude Medical for about $25 B.
• In the last years three Boston Scientific, ACIST, and Opsens entered this growing market.
• The key market players are: Abbott Laboratories (St. Jude Medical); Philips (Volcano); Boston Scientific; ACIST; and Opsens.
• Two Major Players: Philips (Volcano); Abbott (St Jude) – both using Piezo technology
• ThreeNewPlayers(last3yrs.):BostonScientific,ACIST,andOpsens-allusing optical technology
• TheexistingFFRsystemsareusingatinypressuresensor(Piezooroptical)thatis mounted at the distal tip of their guide wire.