NEWS PROVIDED BY
THROMBOLEXTM, INC.
June 30, 2021
The U.S. Food and Drug Administration (FDA) has enhanced the Indications for Use for the BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40). 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.
The specific indication reinforces the mission of THROMBOLEXTM and the BASHIR™ family of catheters as devices that not only clear thrombus but also restore blood flow through the vessel.
To continue expanding their device’s Indication for Use, THROMBOLEXTM is currently enrolling in its pivotal RESCUE trial for the treatment of patients with acute sub-massive pulmonary embolism (PE). This trial is using the BASHIRTM endovascular catheter 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 the BASHIR™ Endovascular Catheter
The family of BASHIR™ Endovascular Catheters is specifically designed to be used for Catheter Directed Thrombolysis (CDT) treatment of large clots in the peripheral vasculature. To date, 510(k) clearance has been received from the FDA for seven BASHIRTM catheters, to be used for localized infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The family of BASHIR™ Endovascular Catheters is currently contraindicated in the pulmonary and coronary arteries and neuro-vasculature. The purpose of the RESCUE investigational study is to seek additional clearance for the treatment of sub-massive pulmonary embolism.
About THROMBOLEXTM, Inc.
THROMBOLEXTM, Inc., headquartered in New Britain, PA, is a privately held medical device company dedicated to the development of innovative catheter-based technologies for the treatment of VTE disorders.
The Company designs, develops, manufactures, and markets innovative products and has a unique platform technology that addresses challenging medical conditions and significant clinical needs for the treatment of Venous Thromboembolic disorders. THROMBOLEXTM sells its medical devices to hospitals through its direct sales organization in the United States.
For more information about THROMBOLEXTM, please visit www.thrombolex.com.
Contact
Dr. Brian Firth, Chief Scientific Officer – THROMBOLEXTM, Inc.
