Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Cardiovascular Systems

FDA grants PMA for Cardiovascular Systems, OrbusNeich Scoreflex scoring balloon

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Cardiovascular Systems and OrbusNeich this week announced that the OrbusNeich Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter has received FDA premarket approval. Scoreflex NC is a force PTCA scoring balloon with a dual-wire system that creates a focal stress pattern for safe and controlled plaque modification … [Read more...] about FDA grants PMA for Cardiovascular Systems, OrbusNeich Scoreflex scoring balloon

Cardiovascular Systems’ recall of its Wirion embolic protection device is Class I

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The FDA determined that Cardiovascular Systems’ recall of some of its Wirion embolic protection devices is Class I, the most serious kind. St. Paul, Minnesota–based Cardiovascular Systems is recalling all products and lots of its Wirion embolic protection device due to complaints of filter breakage during retrieval. It includes devices with … [Read more...] about Cardiovascular Systems’ recall of its Wirion embolic protection device is Class I

Cardiovascular Systems launches peripheral balloon catheter

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Cardiovascular Systems (NSDQ:CSII) today said it has launched its OrbusNeich Jade percutaneous transluminal angioplasty over-the-wire balloon catheter in the U.S. Jade is an over-the-wire (OTW) balloon catheter for the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae and post-dilation of … [Read more...] about Cardiovascular Systems launches peripheral balloon catheter

4 catheter-based devices to watch for in 2021

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Medical device companies are working to gain regulatory approvals and launch new catheter-based devices as the world slowly returns to normal after reeling from the COVID-19 pandemic. As of April 19, the FDA had approved 11 medical devices this year — two of them catheter-based. In comparison, the regulatory agency approved 19 devices by April … [Read more...] about 4 catheter-based devices to watch for in 2021

Cardiovascular Systems acquires WavePoint Medical’s peripheral support catheters

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Cardiovascular Systems today announced that it has acquired a line of peripheral support catheters from WavePoint Medical for an undisclosed amount. Through the acquisition, WavePoint will also develop specialty catheters for treating chronic total occlusions and complex percutaneous coronary intervention procedures for Cardiovascular Systems. … [Read more...] about Cardiovascular Systems acquires WavePoint Medical’s peripheral support catheters

Cardiovascular Systems, Chansu Vascular Technologies partner to develop drug-coated balloons

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Cardiovascular Systems recently announced that it has partnered with Chansu Vascular Technologies to develop a new drug-coated balloon technology. Through the partnership, Cardiovascular Systems and Chansu Vascular Technologies will develop peripheral and coronary everolimus drug-coated balloons. Cardiovascular Systems will provide … [Read more...] about Cardiovascular Systems, Chansu Vascular Technologies partner to develop drug-coated balloons