Medical device manufacturing and the need to adapt

My husband died October 8. Luckily, he was administered CPR by some good Samaritans as soon as he went into cardiac arrest. With their quick, efficient actions, he survived a massive heart attack to make it to the hospital, where a stent was placed in his 99-percent blocked artery. He’s doing OK, now, thanks to some amazing people and a stent that was implanted in his artery by a highly skilled physician.

We are grateful to the many people who came to his aid, and we also are grateful for the stent and countless other medical devices fabricated and used every day to improve and even save lives. Chances are you, or someone you know is the proud owner of such a device.

A stent is a small mesh tube that's used to treat narrow or weak arteries—blood vessels that carry blood away from your heart to other parts of your body.

According to information on The National Heart, Lung, and Blood Institute (NIH) website, stents usually are made of metal mesh, but sometimes they're made of fabric. Fabric stents, also called stent grafts, are used in larger arteries.

My husband received neither a traditional metallic nor a fabric stent. His is a bioresorbable stent approved by the U.S. Food and Drug Administration just this year.

Manufactured by Abbott, Abbott Park, Ill., The Abbott Absorb stent is made of a naturally dissolving material, similar to dissolving sutures. It disappears completely in approximately three years, after it has done its job of keeping a clogged artery open. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated. No metal also means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities.

We are hopeful that this stent will perform as intended and create no serious side effects.

Upon learning about the stent, the thought crossed my mind that metal manufacturers had been accustomed to making metallic stents, which first were available in 1988. What issues did they face moving from metal to the bioresorbable material? Were metallic stent manufacturers able to transition easily to working with a different substance? What changes in processes and equipment, if any, were required?

These are questions I’ll be asking the next fabricator I encounter. I’ll have many opportunities to ask them next week at FABTECH® in Las Vegas. My husband will be there, and seeing him will remind me to ask.