BD Launches New Crosser iQ CTO Recanalization System That Uses Built-In Intelligence to Cross CTOs

January 14, 2022 – BD (Becton, Dickinson and Company) announced the launch and 510(k) clearance from the U.S. Food and Drug Administration of the Crosser iQ™ CTO Recanalization System, which is designed to help physicians cross peripheral artery chronic total occlusions (CTOs) intraluminally.

It is estimated that up to 40% of the symptomatic peripheral arterial disease (PAD) patients may have a completely occluded vessel^1,2 and patients with CTOs often suffer from disabling claudication or critical limb ischemia.³ Crossing CTOs may be challenging and can lead to procedure failure, prolonged procedure time, increased fluoroscopy time, periprocedural complications, and repeat interventions.⁴ The Crosser iQ™ Ultrasonic CTO Device was developed to help improve CTO crossing predictability to aid clinicians treating these challenging lesions.

“There are various aspects of PAD cases that may be challenging, especially crossing a CTO intraluminally. This device uses sophisticated technology to help add predictability to intraluminal peripheral artery CTO crossing,” said Dr. JD Meler, VP Medical & Clinical Affairs, BD Peripheral Intervention.

BD has created its next generation CTO crossing device, which pairs the Crosser iQ™ Ultrasonic CTO Device with the BD Recanalization System and the Recon™ Support Catheter. The new system utilizes proprietary technology that automatically adjusts its crossing power output to help stabilize the distal tip of the device to assist in crossing through the entire length of the CTO intraluminally.

The device utilizes a unique mechanism of action specifically designed to vibrate against peripheral arterial CTOs creating an intraluminal channel to facilitate the placement of conventional guidewires. During the procedure, power from the BD Recanalization System is converted into ultrasonic vibrational energy causing micro-bubbles to expand and implode at the tip of the Crosser iQ™ Ultrasonic CTO Device. This breaks the internal structure of the plaque and erodes the solid surface of the CTO, allowing the physician to automatically and selectively ablate plaque, while remaining atraumatic to elastic tissue.

“Our team is committed to bringing new and innovative tools for clinicians in the fight against PAD.  The enhanced, next generation Crosser iQ™ Ultrasonic CTO Device is a great example of a product that fits perfectly into our larger portfolio of innovative devices and is designed to help physicians successfully cross CTOs," said Tim Hug, VP/GM, BD Peripheral Intervention

The BD Recanalization System and Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The Crosser iQ™ Ultrasonic CTO Device is contraindicated for use in carotid arteries. Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and directions for use.

About BD  

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services, and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease, and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety, and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

References

1. Boguszewski A, Torey J, Pai R, Kamalakannan D, Jefic D et al. (2010) Intraluminal recanalization of SFA CTOs. Endovascular Today 9 33-38.
2. Javed U, Laird JR (2012) Specialty crossing devices: Understanding the learning curve. Endovascular Today 52-57.
3. Liang GZ, Zhang FX (2013) Novel devices and specialized techniques in recanalization of peripheral artery chronic total occlusions (CTOs)--a literature review. Int J Cardiol 165 (3): 423-429.
4. Javed, U. & Laird, J.R. Specialty crossing devices: Understanding the learning curve. Endovascular Today, 52-57 (2012). 5. Singh, G.D., et al. Endovascular recanalization of infrapopliteal occlusions in patients with critical limb ischemia. Journal of vascular surgery 59, 1300-1307 (2014)