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Surmodics receives FDA 510(k) clearance for Pounce XL thrombectomy system
Surmodics has announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its Pounce XL thrombectomy system. The Pounce system is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels…
First-in-human study of SonoThrombectomy system completed
SonoVascular has announced the successful initiation of its first-in-human study (FIH) of the company’s SonoThrombectomy system, an ultrasound-facilitated, thrombolytic-enhanced platform that utilizes multiple mechanisms of action to treat patients with venous thromboembolism (VTE). The catheter-based system combines microbubble-mediated cavitation with…
Thrombolex announces new insights from the RESCUE trial with the Bashir endovascular catheter
Thrombolex has announced never-before-reported major reductions in obstruction in all of the segmental pulmonary arteries (PA), based on independent core lab data analysis of 107 patients from 18 sites in the USA, with acute intermediate-risk pulmonary embolism (PE), using the…
RESCUE trial shows reduction in segmental and main pulmonary artery occlusions
Robert A. Lookstein, MD, who is executive vice chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital in New York today presented the results of a subanalysis of Thrombolex’s National Heart, Lung and…
Study shows increase in risk of renal failure following lytic therapy for acute DVT
A large, single-centre retrospective study has revealed the risk of acute kidney injury (AKI) following pharmacomechanical thrombolysis (PMT) for lower-extremity deep vein thrombosis (DVT) is as high as 22%. This findings add “significant knowledge” to understanding the risks of lytic…