The ByCross is a minimal invasive, single use and fully disposable rotational atherectomy device with an expandable a-traumatic tip, including a simultaneous non-clogging aspiration system. While ByCross is introduced over a guidewire, it does not require the passage of an occlusion with the wire first, therefore, in such completely blocked occlusion whereby guidewire passage cannot be facilitated, instead of aborting the procedure, ByCross enables the completion of re-vascularization percutaneously.
ByCross is designed to restore blood flow in many types of lesion morphologies encountered with Peripheral Vascular Disease (PVD). The ByCross consists of a motor driven coaxial flexible rotating shaft that accepts standard 0.035" guide wire and is accommodated inside a 6F introducer sheath. The shaft rotates at ~6000 RPM with an expandable distal tip (1.7-4.7mm) that macerates the atheroma and the thrombus into small particles which are aspirated simultaneously through the 6F sheath into a collection bag.
The ByCross allows injection of contrast material through the distal end of the tip to improve the safety and the control of the procedure. In addition, a remote-control unit which can be mounted onto the introducer sheath allows the physician to operate the device without losing eye and hand contact throughout the procedure. The same hand of the physician holding the introducer sheath can operate the device via the remote-control while the other hand can advance the device into the vessel. The ByCross shaft flexibility facilitates delivery in tortuous anatomy. The device is available in various lengths (40-135cm) for distal anatomy and contra lateral access. Its stainless-steel design provides complete hub-to-tip radiopacity, it operates without the need of capital equipment, pedal or non-sterile equipment, it is powered by lithium batteries that dispose separately of the device as a non-bio-hazard waist at the end of use.
ByCross electronics and embedded software provides visual indications such as readiness for use or malfunction. This software monitors the electrical behavior of the device and provides safety protections in case of malfunction by stopping the rotation.
About Peripheral Vascular Disease (PVD) and available treatment modalities:
Peripheral artery disease (PAD) is a common manifestation of systemic atherosclerosis causing a chronic, slowly developing, and narrowing of the arteries. Lower extremity peripheral artery disease (LE-PAD) typically affects lower limbs with a frequency that is strongly age-related (~20% of the population older than 55). 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.
A number of pharmacological and invasive strategies have been developed over the last decades to improve the clinical outcomes of patients affected by LE-PAD. In the past, bypass surgery was the standard of care for patients with severe claudication and CLI. Recently, technological advances favored a significant evolution of percutaneous revascularization therapies that now can be offered as treatment options less invasive than traditional surgery. There are several options including percutaneous transluminal angioplasty (PTA), stents, drug-coated balloons, crioplasty, percutaneous thrombectomy (rheolytic and aspiration thrombectomy) and atherectomy. In particular, the promise of atherectomy is 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. Various atherectomy methods are available including plaque excision (directional) atherectomy, laser atheroablation, rotational aspiration/atherectomy and orbital atherectomy.
Procedural success rates have been historically lower in the setting of chronic total occlusion that account for up to 20-40% of patients with LE-PAD undergoing percutaneous treatment. In addition, a number of potential complications (in particular, distal embolization, plaque shift and perforation) may contribute to disappointing results of percutaneous approach to complex infrainguinal disease. Atherectomy, by debulking and removing atherosclerotic plaque cutting or pulverizing atheroma, seems to be a favorable option to increase the spectrum of treatable femoropopliteal lesions such as ostial disease (involving profunda femoral artery), densely calcified plaque, diffuse disease.
The ByCross is a single use, disposable, minimal invasive aspiration rotational atherectomy device (combining rotation with aspiration capability). The ByCross is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. It is also capable of crossing total occlusion when guide wire passage cannot be facilitated. The ByCross can be used in several pathologies: calcified atheroma, old and fresh thrombus.