Spectrum Plastics Group, Alpharetta, Ga.
Earlier this year, a customer asked Spectrum Plastics (Alpharetta, Ga.) to develop a large, soft balloon that could be delivered by a tiny guidewire through narrow coronary vasculature.
The request was unusual, according to Steve Maxson, VP of sales for vascular technologies. The guidewire platform is 4 to 5 French, calling for similarly sized balloon tails, but the balloon itself had to be able to inflate to 30 mm.
“This technology where you have a really large-diameter balloon with really small tails is really unique,” Maxson said. “It’s very difficult to do that. It allows you to reach difficult-to-access anatomy but with a very large-diameter, highly compliant balloon.”
The new balloon required compliant, highly elastic polymers such as polyurethane and low-durometer PEBA. Engineers at Spectrum Plastics’ Earnan balloon technology facility in Wexford, Ireland, did the work. It took a few weeks, according to Maxson.
“We knew it would be a challenge,” he said. “It’s always under the guise of a ‘best effort,’ meaning we can’t guarantee it, but we can give it a shot. Then we developed the appropriate polymer technology and extrusion technology that allowed us to do it.”
There are certain parameters within the extrusion process that enabled the physical properties required to make it happen, according to Maxson, who declined to elaborate, citing customer confidentiality.
“It was an iterative process,” he said. “It’s not like we got it the first time.”
This article has been updated with information from Biomodex and Spectrum Plastics Group.