Lessons Learnt: Tough Call Leads to Greater Device
Image credit: LimFlow
In an interview with Medical Design and Outsourcing, LimFlow Chief Executive Officer, Dan Rose revealed the emotional tough call which ultimately led to the latest version of its innovative system for transcatheter arterialisation of the deep veins (TADV).
Designed to re-establish blood flow in deep veins, the pioneering LimFlow system is used in patients with chronic limb-threatening ischaemia who have exhausted all other treatment options and are facing amputation.
The system works using an arterial catheter needle inside the tibial artery, puncturing the adjacent tibal vein at the exact spot where LimFlow’s venous catheter is placed. Using a guidewire between the two catheters, a self-expanding nitionol crossing stent is surgically placed to direct blood from the blocked artery to the vein, and thereby restoring oxygenation to the foot.
Initially, Rose said, a non-imaging ultrasound was used to help line up the two catheters, with one catheter emitting a signal and the other receiving. However, the company soon learnt that cost and complication could be reduced by instead designing the venous catheter to expand the vein and bring about an easier target.
It was a tough call, Rose said, particularly as LimFlow had already put significant investment into developing and testing the system for its European CE mark certification.
“It means shelving a lot of IP, it means shelving a lot of investment, going to your board and saying, ‘Hey, wait a minute. We did that, and now we think we can do it more easily,’” Rose said.
“But the fact is, if you think about the way technology works, you can either innovate ahead of what may be your competition and make it simpler and easier, or you can wait for them to force you to do it.”
The tech was approved by the United States’ Food and Drug Administration (FDA) earlier this year based on successful findings from its pivotal trial, which saw 76 percent of patients avoid amputation and experience progressive wound healing.
In further LimFlow news, the company this month announced it is set to be acquired by Inari Medical later this year, to a value of up to US$415 million.
Read the full interview with Dan Rose via Medical Design and Outsourcing, and check out the full media statement relating to LimFlow’s upcoming acquisition with Inari Medical.
