Originally Published MPMN November 2002

HOTLINE

Crimping Machine Designed to Process Coated Stents

Equipment resolves contamination and product defect issues

To eliminate what it considers to be drawbacks in existing stent-crimping equipment that may damage coatings, Fortimedix (Nuth, Netherlands) has developed a device that includes a number of features designed to protect coated stents. The Coated Stent Crimper was introduced at the MEDTEC Ireland Conference & Tabletop Exposition held in Galway, Ireland, in September.

As coated stents become more widely used, it is time to address contamination and product defect issues associated with traditional crimpers, says general manager Marc van de Graaf. Users may be faced with "contamination issues, requiring them to clean indenters and other components more frequently," he says. "And the equipment may damage the coatings or leave tool marks, especially when it is used to process soft polymer carriers." To resolve these concerns, Fortimedix has developed a cartridge that protects the stent during the positioning and crimping process.

"The stent's movement through the machine is a noncontact operation," says manager of sales and marketing Henk Meens. "And during the crimping phase, a vacuum-activated sleeve inserted between the stent and the indenters protects the coating," he adds.

The sleeve can be easily replaced to accommodate various coating formulations. Henk adds that stents of different diameters and lengths can be processed without changing the tooling. The machine is also suitable for use with grafted and noncoated stents.

In addition to the safeguards designed to protect coated stents, the machine incorporates all of the features of the company's popular Universal Stent Crimper. The PLC-driven equipment promises high yields and short cycle times. The technology is based on a force-control principle: crimping continues until an equilibrium of forces is achieved. Precrimped profile measurements, tool changes, and adjustments are not required during normal operation.

The company offers a range of related equipment suited for stent manufacturing. Its Stent Pre-Reduction Machine enables the reduction of stent diameters prior to crimping to obtain optimal stent-to-balloon diameter ratios. It has also developed a heat-set machine for postcrimping operations. The machine reportedly enables users who have adopted direct stenting manufacturing practices to achieve improved stent retention, edge protection, and profile smoothness.

Norbert Sparrow

Fortimedix B.V., Horselstraat 1, 6361 HC Nuth, Netherlands; phone : +31 45 5449520; fax : +31 45 5449525; e-mail: [email protected]; Internet: www.fortimedix.com.

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