Purpose: As the number of intravascular procedures increases along side the need for better navigation and accuracy , an innovate device with superior technology is needed.
The Bendit 2.7 is a noval microcatheter with a steerable distal tip controlled through a proximal steering handle.
unique technology facilitates tip control and distal torquability with locked tip deflection.
The tip deflects up to 180 degrees in one direction on a radius of 3 mm , it can be rotated bi-directional by turning the torque knob on the steering handle.
These are the first procedures clinically reported made with the Bendit 2.7 as part of a prospective multicenter open label clinical trial which was approved by the institution IRB committee.
Material and methods: After obtaning a separate informed consent , 8 procedures in 8 patients underwent using the Bendit 2.7.
procedures included PTA of the, R.common iliac Artery , Hepatic radioembolization , Hepatic Tc mapping , embolization of groin tumor , and kidney procedures including infected implanted kidney and AML embolization .
The device was used instead of a standard microcatheter.
AE data were collected in a specific form in all selected procedures immediately at the end of each procedure.
Results: 7 out of 8 patients didn`t present adverse events or device disadvantage during the procedures.
In one procedure a perforation of a vessel occurred during beads injection to an AML which was attributed the abnormal vessel in the lesion.
The perforated vessel was embolized with onyx using the Bendit 2.7. with success.
The Bendit 2.7 allowed all standard functions of a microcatheter with enhanced maneuvering ability.
However , limitation were experienced in situations where the bendit 2.7 was used through a pre shaped guiding catheter which was not deep enough in the target vessel.
Conclusion: According to the first ever human experience with the Bendit 2.7 , it is safe to use and may offer an alternative to the standard microcatheter.
