New medical technologies fuel Polyzen's growth

Polyzen (Apex, NC) is expanding capacity and adding employees to meet rapidly growing demand for its proprietary medical materials, including a new polyurethane film for low-pressure balloons used in cardiovascular and other surgeries.

The 70-plus employee company has added about 25 employees in the past year, and may add another 25 in

Specialized film welding creates 3D balloons with high neck-to-body ratios.

the coming year depending on release dates for planned programs, Polyzen President Rich Kindberg told Plastics Today in an interview.

"Most of the new hires have been in production, but we have added front-office personnel, including engineering as well," he said. "We had a big growth last year, and this year we are hoping to do the same."

Equipment will be added in "the same sweet spot" where it currently operates: film extrusion, dip molding, RF welding, assembly and packaging in Class 10,000 clean rooms, skiving, and lay flat tubing, Kindberg said.

Latex replacement

Growth is being fueled by new products and processes for specialized medical applications, many of which target replacement of latex, which can create allergic reactions.

A new series of thermoplastic polyurethane films from Polyzen can be thermoformed, then welded together to form a medical balloon that achieves neck-to-body ratios unattainable with dip molding, according to Kindberg

The Polyzen low-pressure balloons can be produced in any size and configuration as small as 0.200 inches and offered in 1:5, 1:10, and 1:20 neck-to-body ratios, and any variation in between. They can be produced in thicknesses ranging from 1 to 10 mils.

Previously, the configuration of non-latex, low-pressure balloons was considered undesirable due to limitations of the two-dimensional form, and the low-pressure (between 1-2 psi) was too low for certain medical applications. The patented process allows pressures up to 5 psi. Polyzen also considers welding to be a core competence, and in this case allows production of three-dimensional shapes with strong seams.

Applications for the Polyzen low-pressure polyurethane balloons include gastrointestinal and vascular devices, as well as catheters used for drug delivery.

Inflatable support for surgeons

Polyzen was awarded a US patent last year for a prostate immobilization balloon based on proprietary thermoforming and RF welding capabilities. The device provides inflatable support that is articulated to provide precise positioning and cradling of the prostate during radiation therapy.

Another growth area for Polyzen is dip molding and coating of both polyurethane and silicone materials.

Assembly and packaging are growing at Polyzen, a medical contract manufacturer.

Polyurethane and silicone require a solvent to become liquids. In dip molding, a positive mold (a mandrel) is heated and dipped into a resin/solvent solution and then removed. Multiple dipping builds up wall thickness.  After the material cures on the mandrel, the product is stripped off. It's a cost-effective way to make thin-film products for low-volume applications because tool costs are low.

It can be difficult, however, to mold thin films free of pin holes. Handling of the solvents can be expensive.

Liquid injection molding is used to produce silicone parts in higher volumes. Blow molding is used for high-volume production of polyurethane parts.

Kindberg said that Polyzen does not disclose specific equipment capabilities for competitive reasons.

Polyzen was formed in 1991.




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