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CTO CROSSER® CTO Recanalization System

Restore Flow Through a CTO.
For patients with complete arterial blockages, the CROSSER® CTO Recanalization Catheter is a catheter system designed to treat patients’ Chronic Total Occlusions (CTOs) by forming a new channel within a blocked artery for blood to pass through to allow subsequent endovascular treatment options, such as angioplasty and stenting. The CROSSER® Catheter offers a specialized tip that uses mechanical vibration and cavitation applied directly to the location where plaque has occluded the vessel. The treatment is delivered throughout the entire length of the blockage until it crosses through the distal CTO cap, restoring central lumen access and blood flow.

PATRIOT Clinical Study
The CROSSER® CTO Catheter trial had an 83.5% success rate in crossing CTOs that could not be crossed by a guidewire. There were no clinical perforations of the artery and average time to cross the lesion was 2 minutes and 6 seconds (n=85).

How it Works
The CROSSER® CTO Catheter mechanically vibrates against the CTO and uses micro-bubbles that expand and implode breaking the molecular bonds and eroding the solid surface of the CTO.


Safety information

Indication for Use: The CROSSER® Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The CROSSER® Catheter is only intended for use with the CROSSER® Generator. Refer to the CROSSER® Generator Manual of Operations for proper use.

Contraindications: The device is contraindicated for use in carotid arteries.

Adverse Effects: As with most percutaneous interventions, potential adverse effects include: Bleeding which may require transfusion or surgical intervention, Hematoma, Perforation, Dissection, Guidewire entrapment and/or fracture, Hypertension / Hypotension, Infection or fever, Allergic reaction, Pseudoaneurysm or fistula Aneurysm, Acute reclosure, Thrombosis, Ischemic events, Distal embolization, Excessive contrast load resulting in renal insufficiency or failure, Excessive exposure to radiation, Stroke/CVA, Restenosis, Repeat catheterization / angioplasty, Peripheral artery bypass, Amputation, Death or other bleeding complications at access site.

Three primary components that have the potential to reduce the risk of amputation even in advanced stages of Critical Limb Ischemia (CLI).

CASE STUDY CLINICAL EXPERIENCE:
Neil E. Strickman, MD and Federico E. Azupurua-Gil, MD
Texas Heart Institute / St. Luke’s Hospital
Houston, Texas

VASCUTRAK® PTA Dilatation Catheter and CROSSER® CTO Recanalization Catheter Successfully Relieves CTO of the Anterior Tibial Artery

Patient Overview
A 47-year-old male was admitted to the hospital with left leg critical limb ischemia (CLI), osteomyelitis and a non-healing ulcer of the left foot.

Procedural Highlights
An angiogram revealed the posterior tibial was 100% occluded proximally, the peroneal artery was diffusely diseased while the anterior tibial (AT) had a short 4cm chronic total occlusion (CTO). It appeared the only way to save the leg and foot was to open the CTO of the AT allowing more blood to flow distally to the foot. A CROSSER® CTO Catheter traversed the CTO of the AT and a VASCUTRAK® PTA Catheter was advanced and inflated at the site of the occlusion.

Discussion
Post interventional intravascular ultrasound (IVUS) and angiographic results showed no significant residual stenosis or dissection. The use of the CROSSER® Catheter and VASCUTRAK® Catheter in this location provided an alternate approach to stenting a CTO.


The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes. The physician has been compensated by Bard Peripheral Vascular for the time and effort in preparing the above case study for Bard’s further use and distribution. N.E. Strickman is currently a consultant for Bard Peripheral Vascular, Inc.

Total occlusion of AT.
AT post-recanalization with a CROSSER® Catheter and post-dilation with a VASCUTRAK® Catheter.
IVUS post-recanalization with a CROSSER® Catheter.
IVUS post-dilatation with a VASCUTRAK® Catheter.

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