Home

About Us

Background

Management Team

Scientific Advisory Board

Products

The Problem

Current Solution

FirmGrip

Other Products

FAQs

Contact Us

FAQs

Q. How do the Flexicath systems reduce infections?

A. Flexicath’s FirmGrip system introduces the catheter from within its sterile packaging. It cannot be touched throughout the introduction into the vein, so there is no chance of touch contamination or contact with airborne pathogens during insertion.

Q. Does the FirmGrip system eliminate the need for good site preparation?

A. No. The device does not prevent any contamination that comes through the skin after the introduction of the catheter (micro vibrations) or from poor preparation of the insertion site.

Q. What type of catheter is contained in the FirmGrip.15?

A. The FirmGrip is a 20 cm (8 inches) polyurethane, midline-type catheter.

Q. What size/gauge is available?

A. The FirmGrip is a general 3F catheter that replaces any extended treatment IVs used today in multiple cannulas and midlines.

Q. Does the FirmGrip.15 remain sterile inside after opening the outer package?

A. The product remains sterile for 10 minutes after it has been exposed to the air.

Q. Does the procedure require sterile sheeting?

A. The simplified insertion procedure does not require the placement of sterile sheeting because the silicon sleeve prevents any possibility of touching the catheter throughout the entire procedure.

Q. How long is the FirmGrip catheter expected to stay in the vein without the appearance of phlebitis?

A. The FirmGrip is designed to fill the gap of midrange catheterization periods — usually from 4 to 15 days.

The FirmGrip.15 products/other products is designed for both extended dweller and midline type applications. There is significant data about midlines of comparable length remaining for 30 — and even 200 days — in the vein.

Q. How cost-effective is the Flexicath system?

A. The innovative IV systems developed by Flexicath reduce the preparation time, do not require an external sterile field, and allow a cleaner (no blood backflow) and easier insertion. They enable wider use of PICC and midline catheters in procedures that currently require multiple insertions of a standard cannula.

Q. How would the catheter be inserted?

A. There are a number of possibilities. The standard peel-away introducer inserted in our patented Peel-Guard device allows peeling the introducer without first extracting it from the vein. The catheter that remains in the vein is a midline PU catheter. Both the catheter tube and the introducer are off-the-shelf, standard products.) As mentioned earlier, the product submitted has an approval as a PICC replacement with no limit on dwelling time.

The second insertion technique is through an existing standard cannula with the option of leaving the regular cannula in the vein. This will act as an extended dweller and may reduce the actual cost of the procedure. We anticipate starting to gather clinical data in 2008 to support the use of the standard cannula as an inserter.

Q. Are Fleixcath products approved by the FDA?

A. Yes. The basic system is patented and approved by the FDA for sale in the United States.

Q. Are Flexicath products considered safety devices?

A. The current version of the product uses an unprotected needle (similar to the standard TFX introducers), which are not considered safety devices. Flexicath is currently at work on integrating a safety needle into the introducer. It should be available for sale in Q4 2008.

The needle-safe aspect of Flexicath products are also intrinsically related to their use. They are designed to replace multistick procedures, so using Flexicath systems during procedures that require a number of standard cannulas (where each cannula requires a new needle) will require only one needle. At a later stage, the standard needle will be replaced with a safety needle.