Cardiovascular Systems today announced the first in-human procedures using its Propel percutaneous ventricular assist device. The first patients were treated at Piedmont Heart Institute and Cardiovascular Services in Tbilisi, Georgia by Dr. David Kandzari. The St. Paul, Minnesota-based company reported that Propel performed as intended and … [Read more...] about Cardiovascular Systems treats first patients using Propel pVAD
Cardiovascular Systems
Cardiovascular Systems, Innova Vascular partner to develop thrombectomy devices
Cardiovascular Systems (NSDQ:CSII) announced that it has partnered with Innova Vascular to develop a full line of thrombectomy devices. Under the terms of the agreement, Cardiovascular Systems (St. Paul, Minnesota) will provide financing to Innova (Irvine, California) to develop thrombectomy devices to remove blood clots from arteries and veins. … [Read more...] about Cardiovascular Systems, Innova Vascular partner to develop thrombectomy devices
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren't limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices … [Read more...] about The top 10 catheter innovations of 2021
FDA grants PMA for Cardiovascular Systems, OrbusNeich Scoreflex scoring balloon
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
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
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
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
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
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
