CTO-busting Catheter Provides Solution Where Other Crossing and Re-Entry Devices Fall Short
CAESARIA, ISRAEL, August 15, 2019 /EINPresswire.com/ — Upstream Peripheral Technologies announces that its CTO-busting GoBack™ Catheter received FDA clearance and CE Mark.
The device is instrumental in crossing difficult chronic total occlusions in the peripheral vascular system.
“Occlusions of the SFA and other peripheral vessels can be very difficult and painful to recanalize. The GoBack Catheter is an ideal tool for crossing difficult CTO’s. It’s a really nice device and we like it very much because it’s 4 French. You can use it antegrade or retrograde in small arteries. GoBack is definitely successful and easy to use,” explains Dr. Andrej Schmidt, senior interventionalist at the University Clinic of Leipzig in Germany. “Compared to other devices, the GoBack definitely has a sharper needle and a nice orientation marker.”
The GoBack Catheter is a 4 Fr single-lumen crossing catheter which features a curved nitinol needle that serves as an effective crossing tool. The versatile needle can be extended straight or in two different curved positions beyond the GoBack Catheter’s tip. The protrusion length is thumb-selected by the clinician on the device’s handle.
In Europe, the catheter is used as a crossing device for lesions that are difficult to pass, as well as a re-entry device. In the United States, the GoBack Catheter is labeled for crossing.
A radio-opaque marker on the needle’s distal section provides guidance as to the needle tip’s axial and radial positioning. This facilitates easy steering of the instrument in the desired direction. The device is compatible with 0.018” and 0.014” guidewires.
“We believe that having a simple tool that keeps the guidewire in the artery, can alter the guidewire’s direction inside hard plaque, and also bring you back into the true lumen if you end up in the subintimal space, is important. It saves time, money, and eliminates many unnecessary steps during the procedure,” explains Dan Rottenberg, CTO and inventor of the GoBack Catheter.
The GoBack Catheter just launched commercial sales in Germany. First cases in the United States are anticipated in September.
Clinical data from Europe demonstrates a 92% success rate in crossing heavily calcified iliac/femoropopliteal CTO lesions. The GoBack was used only after failure of standard guidewires with or without support catheter techniques. Lesions ranged from 4cm to 55cm in length. There were no associated complications such as perforation or embolization. "In the absence of the GoBack Catheter, cases would have been abandoned," explains Dan Rottenberg.
Upstream Peripheral Technologies, Ltd.
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Source: EIN Presswire