Thrombolex Enrolls First Two Patients in RAPID-PE Study
Thrombolex, Inc. has made a significant advancement in the medical field by enrolling the first two patients in its RAPID-PE clinical study. This exciting development utilizes the innovative BASHIR™ Endovascular Catheter, a tool designed to treat acute pulmonary embolism effectively. The procedure was conducted by Dr. Ayman Iskander, an interventional cardiologist who leads efforts at St. Joseph’s Health Hospital.
Understanding the RAPID-PE Study
The RAPID-PE study is a multi-center post-market clinical investigation that evaluates the safety and effectiveness of a novel approach to pharmacomechanical lysis (PML). This innovative method stands out because it does not require post-procedural thrombolytic infusion, making it more efficient. Utilizing a 0.035” guidewire compatible BASHIR™ Endovascular Catheter, the study seeks to determine how safely and effectively patients with acute intermediate-risk PE can be treated.
Key Highlights from the Initial Treatments
During the initial treatments, both patients benefited from rapid discharge, showing promising health a mere 24 hours post-procedure. The study protocol involved administering pulse sprays of r-tPA directly into each pulmonary artery, which contrasts with traditional methods that often necessitate longer recovery. Dr. Iskander highlighted that both patients exhibited significant improvements in their hemodynamics, suggesting a quick and effective response to the treatment. The impressive treatment times—38 minutes for bilateral application and 16 minutes for unilateral—indicate a highly efficient procedure.
Research Support and Future Implications
Dr. Wissam Jaber, a key figure in the study and the Director of the Cath Lab at Emory University, expressed optimism about the initial results. The RAPID-PE study is built on the foundation of the RESCUE Study, which previously established the effectiveness and safety of treatments for patients with intermediate-risk pulmonary embolism. It enrolled 109 patients across 18 hospitals, and the RESPUE-II study encapsulated its findings using an on-the-table protocol.
Innovative Technology by Thrombolex
Founded in 2016, Thrombolex has been at the forefront of developing advanced endovascular catheters specifically engineered for interventional procedures. Their focus primarily lies in the field of pharmacomechanical lysis (PML), catering to patients who battle arterial and venous thromboembolic conditions. Currently, Thrombolex has a solid portfolio of eight FDA-cleared devices that leverage their state-of-the-art BASHIR™ platform technology.
Contacting Thrombolex for More Information
For those seeking additional information regarding the ongoing studies or the devices offered by Thrombolex, direct inquiries can be made to Thrombolex via email at info@thrombolex.com. Furthermore, comprehensive details are available on their official website www.thrombolex.com.
Frequently Asked Questions
What is the RAPID-PE clinical study?
The RAPID-PE study investigates the safety and efficacy of the BASHIR™ Endovascular Catheter for treating acute pulmonary embolism.
Who conducted the first treatments in the RAPID-PE study?
Dr. Ayman Iskander, an interventional cardiologist, performed the initial treatments of the enrolled patients.
What are the benefits of the BASHIR™ Endovascular Catheter?
This catheter allows for on-the-table pharmacomechanical lysis, eliminating the need for post-procedural thrombolytic infusion, which enhances recovery time.
How did the initial patients respond to treatment?
Both patients showcased improved health and were discharged within 24 hours after experiencing significant changes in their hemodynamics.
Is Thrombolex involved in any other studies?
Yes, Thrombolex continues to develop innovative therapies and has previously conducted the RESCUE Study, which laid the groundwork for the current RAPID-PE study.
