The Eximo technology complements AngioDynamics’ leading thrombus management and venous insufficiency technologies.
This transaction expands AngioDynamics’ existing Vascular Interventions and Therapies (VIT) product portfolio by adding Eximo’s proprietary laser technology, which has received 510(k) clearance for use in the treatment of Peripheral Artery Disease (PAD). The transaction is being funded exclusively through the use of cash on hand.
(NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that it has acquired Eximo Medical, Ltd., an early commercial stage, medical device company, and its proprietary 355nm wavelength laser-technology platform for $46 million in up-front consideration with up to $20 million of contingent consideration related to certain technical and revenue milestones. All rights reserved.LATHAM, N.Y.-( BUSINESS WIRE)-AngioDynamics, Inc. The device has a high safety profile including a low risk of distal embolization.Īspiration Calcified lesions Denovo disease Distal embolization In-stent restenosis Laser Peripheral arterial disease Restenosis Solid-state laser.Ĭopyright © 2018 Elsevier Inc. The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. A significant improvement from baseline in ABI (0.24 ± 0.18), Rutherford category (-1.79 ± 1.22) and WIQ (0.26 ± 0.28) were noted at 1 month. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ± 14.2% meeting the primary efficacy endpoint goal. Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ± 12.2 (femoro-popliteal 85.6 ± 12.8% tibials 86.0 ± 9.6%). Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). Mean lesion length was 53.96 ± 43.18 mm and 26.2% had severe calcification. Mean age was 70.5 years and 51% were males. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death.Ī total of 97 subjects (107 lesions) were enrolled. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone.
The study enrolled patients in the United States and Europe.
#KABE EXIMO TRIAL#
pivotal trial of the EXIMO B-Laser™.ĮX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. We present the results of the EX-PAD-03 U.S. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm.
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