Michael Barbella, Managing Editor04.12.22
Transit Scientific has received U.S. Food and Drug Administration clearance to use its XO Cross Support Catheter Platform for coronary purposes. The platform is designed to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges, and provide a conduit for delivery of saline solutions or diagnostic contrast agents.
"This new coronary 510k clearance helps us continue to build on the clinical success we've had with our XO Cross for peripheral platform," said Greg Method, president and CEO of Transit Scientific in Park City, Utah. "This is an important milestone for our team as it further expands our mission of delivering novel and effective technologies for the treatment of arterial and venous disease."
Support catheters help navigate guidewires through complex lesions and facilitate guidewire exchanges during interventional procedures in patients with coronary or peripheral artery disease. Legacy technologies often fail to provide sufficient guidewire support, are prone to kinking, and lack the pushability needed to successfully cross severe calcifications and plaque.
The XO Cross Support Catheter platform is designed to deliver new levels of pushability, trackability, flexibility, and torque response for access in challenging lesions and tortuosity. The non-tapered metal-alloy and polymer construction delivers high fatigue-resistance against tough complex lesions found in advanced coronary artery disease (CAD), peripheral artery disease (PAD), and critical limb ischemia (CLI).
"We need better more controllable, and more durable microcatheters and technology for use in complex coronary lesions and chronic total occlusions (CTO)," said Vasili Lendel, M.D. interventional cardiologist at Arkansas Heart Hospital in Little Rock. "The trackability and high-torque response of the XO Cross Platform will help us gain wire access in challenging coronary tortuosity and worst-case calcium and plaque. We've seen great results with XO Cross in our peripheral vascular procedures, so we look forward to using this platform for percutaneous coronary interventions (PCI)."
Transit Scientific will launch the 2Fr Coronary XO Cross 014 Microcath for use with standard 0.014-inch guidewires in 90cm, 135cm, 150cm, and 175cm working lengths. The non-tapered shaft and tapered polymer tip offer a low crossing profile and facilitate coaxial use through any 035 compatible coronary guiding catheter.
Transit Scientific is a commercial stage medical device company that designed, developed, and commercialized 34 FDA and CE Mark cleared products between the XO Cross Support Catheter Platform and XO ScoreÒ Scoring Sheath Platform.
"This new coronary 510k clearance helps us continue to build on the clinical success we've had with our XO Cross for peripheral platform," said Greg Method, president and CEO of Transit Scientific in Park City, Utah. "This is an important milestone for our team as it further expands our mission of delivering novel and effective technologies for the treatment of arterial and venous disease."
Support catheters help navigate guidewires through complex lesions and facilitate guidewire exchanges during interventional procedures in patients with coronary or peripheral artery disease. Legacy technologies often fail to provide sufficient guidewire support, are prone to kinking, and lack the pushability needed to successfully cross severe calcifications and plaque.
The XO Cross Support Catheter platform is designed to deliver new levels of pushability, trackability, flexibility, and torque response for access in challenging lesions and tortuosity. The non-tapered metal-alloy and polymer construction delivers high fatigue-resistance against tough complex lesions found in advanced coronary artery disease (CAD), peripheral artery disease (PAD), and critical limb ischemia (CLI).
"We need better more controllable, and more durable microcatheters and technology for use in complex coronary lesions and chronic total occlusions (CTO)," said Vasili Lendel, M.D. interventional cardiologist at Arkansas Heart Hospital in Little Rock. "The trackability and high-torque response of the XO Cross Platform will help us gain wire access in challenging coronary tortuosity and worst-case calcium and plaque. We've seen great results with XO Cross in our peripheral vascular procedures, so we look forward to using this platform for percutaneous coronary interventions (PCI)."
Transit Scientific will launch the 2Fr Coronary XO Cross 014 Microcath for use with standard 0.014-inch guidewires in 90cm, 135cm, 150cm, and 175cm working lengths. The non-tapered shaft and tapered polymer tip offer a low crossing profile and facilitate coaxial use through any 035 compatible coronary guiding catheter.
Transit Scientific is a commercial stage medical device company that designed, developed, and commercialized 34 FDA and CE Mark cleared products between the XO Cross Support Catheter Platform and XO ScoreÒ Scoring Sheath Platform.