Multi Track System
The Multi Track system was specifically aimed at the treatment of patient with mitral stenosis which is prevalent in poor countries. The aim was to provide affordable and effective treatment in patients who would not get access to medical care due to lack of economic resources.
The valve implantation technique was developed initially in association with NuMed alone. However, soon valve and sterilisation technologies for biological tissues needed to be incorporated into the project. For this reason Philipp Bonhoeffer created a partnership with the company VenPro. VenPro was later acquired by Medtronic and the valve project was adopted by Medtronic Inc. in 2005 and the name Melody was given to the valve.
The first human implant of a Transcatheter Valve was performed by Philipp Bonhoeffer in September 2000.
In 2012 the Melody Valve (Medtronic Inc) won the prestigious Galien award for Excellence in Scientific Innovation and Humanitarian Efforts. This in recognition that this was the world’s first transcatheter valve implanted in a human, the first transcatheter valve commercially available anywhere in the world upon gaining CE Mark in 2006, and the first transcatheter valve ever approved in the United States in 2010 when it received approval through FDA’s Humanitarian Device Exemption program.
World wide approximately 1000 Melody valves are currently implanted on a yearly basis.
Philipp Bonhoeffer has participated in developing the regulatory strategy for the Mitral Multi Track catheter and the Percutaneous Pulmonary Valve (MelodyTM, Medtronic). He wrote the application for the first in man trial for the pulmonary valve in France in 2000 and obtained the approval from the national French ethical committee (CCPPRB). Later he has brought the application to England and obtained approval by the Medicine and Healthcare Regulatory Agency (MHRA) for implantation on humanitarian grounds. Then, with Medtronic, he helped to secure CE mark for Europe in 2006. Philipp Bonhoeffer has been actively involved in meetings and presentations for the FDA and has presented at the FDA panel meeting, which gave unanimous support for Melody in 2009. FDA approval under humanitarian device exemption (HDE) was given in January 2010. He has been invited to participate in regulatory meetings to suggest new strategies related to Medical devices by the FDA for the US and the MHRA for European issues. He also acted as a Specialist Advisor to the National Institute for Health and Clinical Excellence (NICE) for their Interventional Procedures Programme in the UK.
Collaboration with Industry
Since 1992 Philipp Bonhoeffer has consulted for the following Companies: NuMed Inc (Hopkinton NY, USA), Medtronic Inc (Minneapolis MN, USA), AGA Medical (Minneapolis MN, USA), Xeltis AG (Zurich, CH), Ven.Pro (Irvine CA, USA) W.L. Gore (Flagstaff AZ, USA), ABMedica (Lainate, Italy).