“We were under pressure from the FDA to explain why our AV fistula device should not cause ‘steal’ from the external iliac artery to the external iliac vein.  Chris was able to provide a clear justification based on a concrete literature review and logic using hemodynamics and exercise physiology.  In addition, Chris was able to widen our clinical trial ankle-brachial index inclusion criteria with a brilliant explanation that incorporated disease severity limits, hemodynamics, improved medical imaging protocol, and inclusion of diverse patient demographics.  This saved us an immeasurable amount of time and money to complete our clinical trial.”

- Rodney Brenneman (CEO, Rox Medical, then E3 MedTech)

“Starlight Cardiovascular is committed to developing devices for neonates with congenital heart disease, a grossly underserved population.  Without anything in the literature to guide the durability aspect of our products, we turned to Chris and his team to help.  They worked with multiple clinical sites to acquire medical imaging data and quantify the impacts of stenting on patent ductus arteriosus (PDA) morphology and pulsatile vascular deformations.  The ensuing data was critical for Starlight’s device design and product evaluation, and led to IDE approval for a pivotal trial with the FDA.  In addition, Chris provided expert support during FDA pre-sub meetings and the data was converted into the world’s first publication on PDA stent biomechanics.”

- Beverly Tang (CEO, Starlight Cardiovascular)

“Chris and his team served as our core lab for the Gore ARISE Trial, a multicenter FDA Early Feasibility Study investigating the Gore Ascending Stent Graft (ASG).  They were instrumental in organizing first-in-human imaging data, quantifying axial, diametric, and bending pulsatile deformations of the device, and defining boundary conditions with which to evaluate the durability of the ASG.  The data also informed physicians about the downstream effects of ascending TEVAR to help guide interventional strategies.  As a bonus, Chris’s team published the results in a peer-reviewed journal and presented the data on the podium at the Critical Issues Conference for excellent exposure.”

- Mike Nilson (Product Specialist (retired), W.L. Gore & Associates)

“When Optimed was working on CE-Mark approval of venous stents for non-thrombotic common iliac vein lesions and iliofemoral veins, we contacted Chris and his team to help define boundary conditions.  Chris had already been involved with several other iliofemoral venous stents under development, so we relied heavily on his depth of experience.  They accumulated patient data sets and using epipolar methods, converted orthogonal 2D projection X-rays into 3D geometries of the stents.  They then quantified the impact of hip flexion (for walking and stair-climbing) on our stents and hip flexion and hyperextension (for walking) to help get approval of the devices.”

- Dr. Achim Zipse (Head of R&D, optimed Medizinische Instrumente GmbH)

“Chris and his team performed a complex study to define the dynamic biomechanical environment of Terumo Aortic’s RelayPro thoracic aortic endograft, and helped us earn three PMA indications from the FDA covering aneurysms/penetrating atherosclerotic ulcers, dissections, and blunt traumatic aortic injuries.  This multicenter study involved acquiring patient data sets, precise imaging analysis, and translation into boundary conditions for durability evaluation.  In addition, Chris’s team published the data in a peer-reviewed journal and presented it on the podium at an international conference, which was beneficial to our product launches after FDA approvals.”

- Scott Rush (Global VP R&D, Terumo Aortic)

“As an integral part of the Bentley team for years, Chris’s team helped us launch our BeGraft and BeFlared bridging stents for complex endovascular aortic repair (EVAR).  They created a novel CT imaging research protocol, helped coordinate imaging trials, quantified device dynamics and interactions with the renovisceral arteries resulting from cardiac- and respiratory-induced influences, and performed finite element analysis for fatigue.  BeGraft became the world’s first on-label bridging stent, BeFlared was the first dedicated bridging stent for fenestrated EVAR, and BeGraft Plus is being investigated for branched EVAR indications.”

- Carmen Panero (Director R&D, Bentley InnoMed GmbH)

“When we needed to derive deformation boundary conditions for stents in the tibial arteries, we knew that Chris was the best person to call.  He and his team developed a novel cadaver model that incorporated knee flexion, ankle plantarflexion and dorsiflexion, and simulated calf muscle contraction.  He strategized the study, handled all cadaver lab and staffing logistics, and executed the study smoothly faster than the agreed upon timeline.  He then wrote up the results, which resulted in the world’s first publication describing stent dynamics in the tibial arteries.  We will definitely contact Chris again to develop complex cadaver models for new product development.”

- Claudio Silvestro (R&D Program Director, Medtronic)