A brief history of NuMED’s contribution to the development of Transcatheter Heart Valve Replacement

The revolutionary procedure that became the standard

In the early 90s Dr. Philipp Bonhoeffer, a pediatric cardiologist at the hospital Necker in Paris, had his initial idea: What if a pulmonary valve were implanted through catheterization instead of the then standard heart valve replacement by surgical sternotomy procedure? At the time, treating pulmonary blockages or leaks through open heart surgery was the standard, corrections to life-threatening conditions that also put significant stress on the body, required a long recuperation period, or further surgeries. Cardiovascular catheterization procedures were becoming more common as innovative and forward thinking device manufacturers, such as NuMED, were introducing minimally invasive cardiovascular devices. Though heart valve replacement was still then considered the domain of cardiovascular surgery, Dr. Bonhoeffer set out to test his idea of implanting a valved stent through catheterization.

But first, the idea had to be tested, the technology created.

Partners in a vision

Development and Implantation

Work began. NuMED, having developed the first septostomy balloon catheter (Z-5™) and Balloon-in-Balloon catheter (BIB®), would manufacture some critical materials like the stent and balloon catheter. But the valve itself had to be harvested. And for this very important component, they had to look no further than NuMED’s backyard.

Located in Hopkinton, a rural city in upstate New York, NuMED’s place of operations was surrounded by cattle farms and slaughterhouses. Early in their process, Dr. Bonhoeffer and NuMED’s staff would visit local slaughterhouses to dissect and preserve the desired segment of bovine jugularveins. These harvested materials were then used to create proofs of concept, testing different stent and catheter combinations until the most promising device for a new treatment methodology came to fruition.

In August of 2000, the first study, “Transcatheter Implantation of a Bovine Valve in Pulmonary Position” by Dr. Philipp Bonhoeffer et al, was published in Circulation. The study discussed tests done on lambs with the device Dr. Bonhoffer had collaborated on with the NuMED team. Thanked in its acknowledgments were “Allen Tower, Mike Martin, (both of NuMED), and Dr. Peter Osypka for their technical and financial support, without which this study would not have been possible.” The publication’s ultimate conclusion was: “The future opportunity to implant pulmonary valves percutaneously in humans will lead to a significant reduction of reoperations. Although the implantation of such a valve is technically difficult in the lamb, application in humans should not fundamentally differ… Therefore, we think that percutaneous pulmonary valve implantation in humans should be possible in the very near future.”

The future was closer than imagined

In September 2000, Dr. Philipp Bonhoffer performed the first human trial on a 12-year-old boy. According to the Telegraph, “The operation was hailed a medical breakthrough because it took half an hour to complete, required local anesthetic and allowed patient to be discharged the following day.”

After this initial success, there came new possibilities. Though it began with pulmonary valve implantation, because of its low profile and effectiveness, treatment expanded to address biological aortic heart valves, which helped a much larger patient population. Today all heart valves can be safely and effectively replaced percutaneously and comprise ninety percent of such treatments.

The legacy of Dr. Bonhoeffer and NuMED’s participation in developing the initial technology cannot be overstated. A procedure that has vastly improved the quality of life of millions throughout the world began with an idea and on-the-ground work in the farmlands of Hopkinton, New York. What once was a vision of a new way to improve quality of life, is now a life-changing reality for many.

NuMED today