Deans' stroke musings: Route 92 announces US FDA 510(k) clearance for FreeClimb 54 reperfusion system

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Wednesday, May 1, 2024

Route 92 announces US FDA 510(k) clearance for FreeClimb 54 reperfusion system

Does your competent? stroke hospital have procedures in place to bring in new stroke interventions? NO? So you don't have a functioning stroke hospital? You'll have to direct the ambulance to a more successful place.

Route 92 announces US FDA 510(k) clearance for FreeClimb 54 reperfusion system

Route 92 Medical has today announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the FreeClimb 54 reperfusion system, comprised of the FreeClimb 54 aspiration catheter paired with a Tenzing 5 delivery catheter.

This new system is part of a growing portfolio of neurovascular devices from Route 92, designed to work harmoniously as a complete endovascular thrombectomy solution to address a broad range of neurovascular interventions, according to a company press release.

“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximise their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, chief executive officer of Route 92. “The FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”

The FreeClimb 54 system can telescope through the company’s complementary products, allowing physicians to rapidly, predictably reach and remove stroke-causing clots during endovascular thrombectomy procedures. Route 92’s recent press release also notes that FreeClimb 54’s robust tip and shaft design facilitates use for multiple passes, and compatibility with other technologies. Additionally, the system may be used to remove distal clots when first-line therapies fail to completely remove the clot.

“The launch of the FreeClimb 54 reperfusion system continues Route 92 Medical’s progressive and complete approach to stroke care,” stated Peter Pema (Riverside Methodist Hospital, Columbus, USA). “This system combines the unparalleled effectiveness and safety of their Tenzing delivery system with an aspiration catheter that can reach far into the cerebral circulation beyond the proximal branch vessels. Thus, the size of the FreeClimb 54 system offers clear advantages to clinicians looking to achieve rapid, safe recanalisation of vessels on the first attempt.”

“The FreeClimb 54 system is a gamechanger,” added Ronald Budzik (Riverside Methodist Hospital, Columbus, USA). “It is a simple system capable of getting a larger bore aspiration catheter to distal anatomy, especially around tighter turns.”