XCOILTM Thrombectomy Product Line
NexGen is developing an integrated catheter-based product line for
removal of blood clots in all vascular territories in the human body.
The XCOILTM product line is comprised of (i) the XCOILTM Retractor mechanical
blood clot retrieval device, (ii) the XCOILTM Guider, a specialized
percutaneous catheter that is designed to facilitate placement and
removal of the XCOILTM Retractor, (iii) the XCOILTM Encapsulator, a nitinol sheath that is designed to work synergistically with the
Retractor to remove large blood clots from the body, (iv) the XCOILTM
Shield, a nitinol cap that is designed to trap and facilitate removal of
blood clot fragments, and (v) the PeriCATHTM, an infusion catheter for
targeted multisegmental delivery of thrombolytic agents to dissolve
any residual clot.
The XCOILTM Retractor is a proprietary catheter-based mechanical retriever for peripheral arterial and hemodialysis graft indications. The device is positioned by angiography-guided percutaneous catheter delivery within the lumen of the blood vessel directly adjacent to the thrombus, and uses a soft coil mesh to engage the surface of the thrombus and a retraction wire to retract the coil mesh with the captured thrombus. The Retractor coils have an adjustable stiffness facilitating control of gripping forces on the thrombus while reducing contact of the device with blood vessel surfaces. The Retractor has been shown in preclinical and initial clinical tests to be safe, easy to use, and effective.
The XCOILTM Retractor is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.
The XCOILTM Encapsulator is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature. The XCOILTM Encapsulator is a single use, catheter-based device designed to facilitate the placement or removal of vascular catheters and devices including the NexGen Medical Systems XCOILTM Retractor. The Encapsulator is comprised of a catheter shaft attached to a braided nitinol tip that expands as the device is deployed from the lumen of a guide catheter. The nitinol braid passively expands to the contour shape of the vessel lumen and allows the XCOILTMRetractor to be retracted into the nitinol braid.
The XCOILTM Guider is a single-use percutaneous access catheter that is designed
to facilitate placement and removal of the XCOILTM Retractor .
Blood clot removal procedures are considered to be high embolic risk interventions in 5-15% of cases. NexGen Medical Systems, Inc. has developed a nitinol medical device to constrain large clots and to trap and facilitate removal of blood clot fragments during clot removal procedures. The Shield will be marketed as part of the Company’s XCOILTM thrombectomy system for both venous and arterial indications.
NexGen’s initial market target is deep vein thrombosis (DVT). Post-thrombotic syndrome occurs in 30-80% of patients with DVT and is associated with large blood clots and long hospitalization periods. Current treatments include (i) anticoagulation, (ii) surgical thrombectomy, (iii) non-surgical percutaneuous thrombectomy, and (iv) catheter-directed thrombolysis. NexGen believes that its integrated thrombectomy product line will produce quick debulking and removal of clot from main veins and collaterals without damaging vessels. On this basis, the Company anticipates that its XCOILTM product line will attain ‘treatment of choice’ status against competitors such as AngioJet, and Trellis, which typically require thrombolytic drugs and multiple passes to remove a blood clot.
NexGen’s second market target is ischemic stroke. 25% of stroke patients suffer from occlusion of the internal carotid artery and its intracranial branches by blood clots. Currently available medical devices for removal of blood clots in stroke patients are difficult to use and generally ineffective in removing hard (fibrin-laden) clots. The only FDA-approved clot-dissolving drug agent (tPA) has a short therapeutic window and significant adverse side effects.
The Company’s XCOILTM Retractor has been shown in pre-clinical tests to reliably navigate tortuous blood vessels to sites of extracranial or intracranial thrombosis and effectively retract a thrombus without fragmentation and without damaging blood vessels. On this basis, NexGen expects to be able to compete favorably against the Merci Retreiver and the Penumbra.
NexGen’s third market target is peripheral arterial disease (PAD). Severe arterial narrowing or poor blood flow commonly results in blood clot formation, which if not immediately corrected can lead to tissue death and limb amputation. PAD affects an estimated 27 million individuals in North America and Europe. It is estimated that only 25 percent of symptomatic patients are currently treated for the disease. Endovascular catheter delivery of a thrombolytic agent to dissolve the clot can be effective, but commonly requires days of drug infusion, intensive care monitoring, and frequent trips to the radiology department to reposition the catheter. Of the 100,000 cases of peripheral arterial thrombosis per year in the US, an estimated 70,000 are treatable with catheter-base thrombectomy and thrombolysis. Another 320,000 individuals with clotted hemodialysis grafts may also be treatable with NexGen thrombectomy devices.