Thrombolex, Inc. - DVT Results with the Bashir™ Catheter.
New Britain, PA, October 14, 2021 --(PR.com)-- The BASHIR™ Endovascular Catheter (BEC) and the BASHIR™ Plus Endovascular Catheters (BASHIR™+ 10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are hybrid devices that enable both mechanical and pharmacological treatment through use of an expandable infusion basket with the ability to infuse thrombolytics. These catheters are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
Vascular Medicine* published a case series of 13 patients from Temple University in Philadelphia, PA with acute symptomatic inferior vena cava (IVC) and iliofemoral deep vein thrombosis (DVT). All the treated patients had complete and rapid resolution of their symptoms with excellent venous outflow. These and other data were presented to the FDA to expand the BEC indication for use to state that the catheter restores blood flow in patients with venous thrombus.
To continue expanding their device’s Indication for Use, Thrombolex is currently enrolling patients in its pivotal RESCUE trial for the treatment of acute submassive pulmonary embolism (PE). This trial is using the BASHIR™ and BASHIR™ S-B Endovascular Catheters under an Investigational Device Exemption (IDE) from the FDA. The goal of RESCUE is to achieve an additional indication for use of the device in the treatment of PE.
About Thrombolex, Inc.
Founded in 2016, Thrombolex is engaged in the design, development, and distribution of innovative endovascular catheters used in interventional procedures, particularly in catheter-directed thrombolysis (CDT) of thrombus in patients who suffer from arterial, venous, and arteriovenous thromboembolic conditions.
Vascular Medicine* published a case series of 13 patients from Temple University in Philadelphia, PA with acute symptomatic inferior vena cava (IVC) and iliofemoral deep vein thrombosis (DVT). All the treated patients had complete and rapid resolution of their symptoms with excellent venous outflow. These and other data were presented to the FDA to expand the BEC indication for use to state that the catheter restores blood flow in patients with venous thrombus.
To continue expanding their device’s Indication for Use, Thrombolex is currently enrolling patients in its pivotal RESCUE trial for the treatment of acute submassive pulmonary embolism (PE). This trial is using the BASHIR™ and BASHIR™ S-B Endovascular Catheters under an Investigational Device Exemption (IDE) from the FDA. The goal of RESCUE is to achieve an additional indication for use of the device in the treatment of PE.
About Thrombolex, Inc.
Founded in 2016, Thrombolex is engaged in the design, development, and distribution of innovative endovascular catheters used in interventional procedures, particularly in catheter-directed thrombolysis (CDT) of thrombus in patients who suffer from arterial, venous, and arteriovenous thromboembolic conditions.
Contact
Thrombolex, Inc.
Tony Litwiller
(844) 792-6300
www.Thrombolex.com
Contact
Tony Litwiller
(844) 792-6300
www.Thrombolex.com
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