The Need

Peripheral arterial disease (PAD) is a common manifestation of systemic atherosclerosis, causing a chronic, slowly developing, and narrowing of the arteries. Lower extremity peripheral arterial disease (LE-PAD) typically affects lower limbs with a frequency that is strongly age-related. Clinical manifestations vary from intermittent claudication (pain in the calves while walking that goes away with rest) to chronic total occlusion (CTO), critical limb ischemia (CLI), gangrene, and, ultimately, limb loss.

While bypass surgery was historically the standard of care for patients with severe claudication, several pharmacological and invasive strategies have been developed over the last decades to improve the clinical outcomes of patients affected by LE-PAD. Recently, technological advances have resulted in less invasive treatment options, which include percutaneous transluminal angioplasty (PTA), stents, drug-coated balloons, percutaneous thrombectomy (rheolytic and aspiration thrombectomy), and atherectomy.

In particular, atherectomy promises to overcome the limitations and complications of traditional angioplasty, such as dissection, elastic recoil, and disruption of the internal elastic lamina: resulting in overwhelming neointima and smooth muscle cell proliferation. Unlike balloons and stents, which push plaque into the vessel wall, atherectomy offers the ability to debulk the plaque burden within the vessel, helping increase the spectrum of treatable femoropopliteal lesions to include ostial disease, densely calcified plaque, and diffuse disease.

The Solution

Designed to restore blood flow in a variety of lesion morphologies encountered when treating peripheral vascular disease (PVD), including calcified atheroma, as well as old and fresh thrombus, BYCROSS® is a bi-directional rotational atherectomy catheter with an expandable a-traumatic tip that is inserted into the peripheral vascular system over a guidewire and an introducer sheath to restore chronically occluded vessels.

The device incorporates a simultaneous non-clogging aspiration system that collects calcified material using an integrated pump.

While BYCROSS® is introduced over a guidewire, it does not require the wire to pass through an occlusion before use. Therefore, in cases where guidewire passage cannot be facilitated, BYCROSS® enables the completion of revascularization percutaneously.

BYCROSS® consists of a motor-driven coaxial flexible rotating shaft that accepts any standard guide wire, at the size of 0.035″ or smaller and is accommodated inside a 6F or larger introducer sheath. The shaft rotates at 4750 RPM with an expandable distal tip (1.9-4.7mm) that macerates the atheroma and the thrombus into small particles, which are aspirated simultaneously through the 6F sheath into a collection bag.

This BYCROSS® shaft flexibility facilitates delivery in tortuous arteries and veins, and it is available in various lengths (50-130cm) for distal anatomy and contralateral access. BYCROSS®’ stainless-steel design provides complete hub-to-tip radiopacity and allows it to operate independently without capital equipment, pedal, or non-sterile equipment. It is powered by lithium batteries that can be disposed of separately from the device as non-bio-hazard waste at the end of use.

By enabling the injection of contrast material through the distal end of the tip, BYCROSS® helps improve the safety and control of the procedure. At the same time, a remote-control unit, which can be mounted onto the introducer sheath, allows physicians to operate the device without losing eye and hand contact throughout.

As an additional benefit, BYCROSS® electronics and embedded software provide visual indications such as readiness for use or malfunction. The software monitors the electrical behavior of the device, and stops its rotation in case of malfunction.