Phraxis Inc. Secures FDA Approval for Innovative Dialysis Device
Phraxis Inc. Achieves FDA Approval for EndoForce™ Connector
Phraxis Inc., a leading medical device company based in Minneapolis, has reached a significant milestone with the FDA's approval of the EndoForce™ Connector for Endovascular Venous Anastomosis. This cutting-edge device is set to revolutionize dialysis access technology and improve patient outcomes.
Understanding the EndoForce™ Connector
The EndoForce™ Connector is designed as a patented endovascular implant aimed at modernizing the creation of arteriovenous grafts (AVGs) essential for hemodialysis. Unlike traditional methods that require surgical dissection, the EndoForce™ enables a precise endovascular anastomosis. This innovation minimizes tissue trauma while ensuring accurate alignment between the vessel and graft.
Key Features of the Device
The design of EndoForce™ includes several innovative features such as anchoring barbs that secure it within the vein, a flexible segment covered with ePTFE that adapts to the vascular structures, and a compressible section that expands within the AVG during deployment. Together, these elements promote stable blood flow and aim to reduce complications associated with graft failure.
Clinical Success and Implications for Dialysis Patients
In comprehensive clinical trials, the EndoForce™ demonstrated remarkable performance, achieving a 92% patency rate at six months, thus meeting key primary endpoints. Such data suggests that the device not only performs effectively but also holds potential for enhancing long-term outcomes for patients undergoing dialysis.
Expert Insights on the Innovation
Dr. John Ross, who served as the principal investigator for the pivotal studies, expressed enthusiasm about the device's potential. He noted, "The EndoForce™ provides a revolutionary approach to AVG creation, enhancing procedural efficiency and addressing many existing challenges faced in vascular access procedures. This could indeed improve patient care significantly."
Message from Phraxis Inc. Leadership
Alexander Yevzlin, the CEO of Phraxis Inc., shared his perspective on this major advancement, stating, "Receiving FDA approval marks a transformative moment for the dialysis community. Our EndoForce™ Connector is set to establish a new benchmark for AVG procedures, combining ease of use with reliability. With ongoing evaluations of long-term outcomes, we are optimistic about the improvements this device can bring to dialysis care and patient experiences."
Availability of the Device
Now that the EndoForce™ Connector has received FDA approval, healthcare professionals and clinicians can access this innovative solution. Phraxis Inc. is dedicated to ensuring that the integration of EndoForce™ into clinical practice is seamless, ultimately enabling healthcare providers to enhance dialysis access for their patients.
Company Background
Phraxis Inc. is committed to advancing technologies that improve vascular access for patients with end-stage renal disease (ESRD). The company continuously aims to tackle critical challenges associated with dialysis access, focusing on delivering durable, innovative solutions that enhance patient care on a global scale.
Frequently Asked Questions
What is the EndoForce™ Connector?
The EndoForce™ Connector is a patented medical device designed to improve the creation of arteriovenous grafts for hemodialysis, minimizing surgical intervention.
What are the benefits of using the EndoForce™?
This device reduces tissue trauma, enhances procedural efficiency, and aims to improve long-term outcomes for patients by promoting stable blood flow.
How successful was the clinical trial for the EndoForce™?
The clinical trial reported a 92% patency rate at six months, indicating strong clinical performance and promising results for patient outcomes.
Who leads Phraxis Inc.?
Phraxis Inc. is led by Alexander Yevzlin, MD, who has emphasized the significance of the EndoForce™ in improving dialysis care.
Where can healthcare providers learn more about the device?
Healthcare providers can access detailed information about the EndoForce™ Connector on the official Phraxis Inc. website.
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