Drug-eluting balloons (DEBs) have been the focal point of intense R&D during the past several years as medical device manufacturers explore alternative and complementary treatments to stents. The emergence of these novel devices, however, has presented unique processing challenges, including the potential for damage and cross contamination during pleating and folding operations. Catering to this next-generation medial device processing need, Machine Solutions Inc. (Flagstaff, AZ) has introduced the FFS975S DEB catheter pleating and folding system, which it claims is the first and only machine designed specifically for processing DEBs.

As with drug-eluting stents (DES), the processing of DEBs is complicated by the incorporation of a therapeutic agent on the surface of a balloon. "[You have] to pleat and fold [the balloon] to get it down to a small profile so that you can insert it into the body. But that process of pleating and folding could damage the drug coating or, worse, take some of the drug off of one balloon and deposit it onto another balloon being processed later," explains Brian Strini, product manager at Machine Solutions. "Doing damage to the drug is bad enough, but increasing the drug dosage on another balloon is even worse. Cross contamination is a huge concern."

Previous attempts at preventing such a dangerous error have proven unsuccessful, according to Strini. Sheathing the DEB with a piece of tubing, for example, is effective during pleating operations but is problematic when folding the device. Because the tubing sheath is pulled into the balloon during the process, it can be difficult to extricate when the operation is completed. This approach also requires an operator to manually introduce the sheath prior to processing the balloon and then remove it at the end, Strini adds.

To address this need, Machine Solutions drew inspiration from its crimping equipment, which protects the drug-coating integrity of DES during processing. Extensive testing with a balloon customer then revealed that the use of a PTFE film during processing effectively created a barrier between the DEB and the stainless-steel elements of the equipment. "As the balloon is placed in the head, it's in an inflated condition. The film wraps around it as the head is closing onto it," Strini says. "The film then takes on the shape of the balloon being pleated and protects it from contacting any of the metal parts of the machinery."

The PTFE film is laced through the head of the system, serving to protect the drug coating during the process. It then cycles out of the head upon completion of the production run. "Every time you put a balloon into the machine, there's a clean sheet of film that's interacting with the product," Strini adds. In addition, the automated nature of the technology bypasses the need for operator interaction while increasing throughput and decreasing cycle times. Able to accommodate all PTCA and most PTA balloons, the FFS975S system yields minimal folded profiles while maintaining coating integrity during balloon pleating, folding, wrapping, and fluting processes.