First Patient Enrolled in Akura Medical's Groundbreaking Trial
First Patient Enrolled in Revolutionary Thrombectomy Trial
Akura Medical, a key player in the field of venous thromboembolism (VTE) care, has achieved a significant milestone by enrolling the first patient in their QUADRA-PE study, which focuses on the innovative Katana™ Thrombectomy System. This trial marks a pivotal advancement in the treatment of acute pulmonary embolism (PE).
About the Katana™ Thrombectomy System
The Katana System is designed to safely and effectively remove various types of blood clots. It combines intelligent design with cutting-edge technology to enhance the performance and outcomes of thrombectomy procedures. The initial procedure took place at a distinguished medical center, under the expertise of Dr. Samuel Horr, who leads cardiovascular research.
Real-Time Feedback for Improved Procedures
One of the major highlights of the Katana System is its ability to provide real-time pulmonary artery pressure readings during the procedure. This feature is crucial for physicians to determine the effectiveness of the clot removal process. Dr. Horr emphasized the importance of this technology in helping to streamline interventions and ultimately providing better care for patients suffering from pulmonary embolisms.
Key Features of the Katana System
The Katana Thrombectomy System encompasses several innovative features:
- A bi-directional, low-profile sheath that allows smoother navigation through complex blood vessels, facilitating effective treatment.
- High velocity saline jets that break up clots, ensuring that the catheter remains clear and efficient during operations.
- Sensors delivering real-time pulmonary artery pressure data, offering insights that are essential for the success of the procedure.
- The Sentinel™ Console, which not only displays important procedural data but also helps minimize uncertainty for the physician.
Challenges in Thrombectomy Procedures
The process of performing a thrombectomy for pulmonary embolism is fraught with challenges. According to Dr. Sanjum Sethi, a co-principal investigator for the QUADRA-PE study, one of the most significant hurdles is accurately determining whether the thrombus has been removed completely. Incomplete removal can result in poor patient outcomes.
Significance of the QUADRA-PE Study
The QUADRA-PE study is an ambitious multi-center trial that aims to enroll up to 118 patients globally. Its primary goal is to assess the effectiveness of the Katana System in reducing the right ventricular to left ventricular (RV/LV) ratio, a key measure of cardiac performance post-procedure. Additionally, the trial will focus on the safety of the device by monitoring adverse events in the days following surgery.
About Akura Medical
Akura Medical stands at the forefront of medical technology dedicated to transforming thromboembolism care. Their flagship product, the Katana™ Thrombectomy System, is aimed at setting new standards in the treatment of pulmonary embolism by providing superior efficacy in clot removal procedures. Akura's mission is centered around improving patient outcomes and reshaping VTE care.
About Shifamed, LLC
Founded by entrepreneur Amr Salahieh, Shifamed focuses on medical innovations that enhance patient care while mitigating risks associated with market introduction. Their commitment is to create a healthier future through groundbreaking solutions and efficient market strategies.
Frequently Asked Questions
What is the Katana Thrombectomy System?
The Katana Thrombectomy System is a medical device designed for the safe and effective removal of blood clots from the pulmonary artery.
What is the QUADRA-PE study?
QUADRA-PE is a multi-center international clinical trial aimed at evaluating the effectiveness of the Katana System in treating acute pulmonary embolism.
Who is involved in the QUADRA-PE trial?
The study involves several leading cardiologists and researchers from different medical centers, including Dr. Samuel Horr and Dr. Sanjum Sethi.
What are the primary endpoints of the QUADRA-PE study?
The main effectiveness endpoint is the reduction in the RV/LV ratio, while safety is assessed through the rate of major adverse events post-procedure.
What advancements does the Katana System provide?
The Katana System offers real-time feedback during procedures, allowing physicians to make informed decisions and improve patient outcomes.
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