Frequently Asked Questions
Why did you decide to crowdfund your device on IndieGoGo?
After Allison's diagnosis, Dave Rezac (Allison's uncle, a medical device engineer, and our VP of Product Development) started asking around and educating himself on relevant new technologies in hopes of finding something in development that could help Allison and others with her condition. He was told that although this type of technology could have serious potential for kids with aneurysms, large device companies most likely would not develop it because the pediatric market is too small. Not one to be easily deterred, Dave partnered with Allison's father, Aubry Shackelford, who also happens to be a licensed professional engineer with a lot of experience in starting companies, and together they formed Pegasus Therapeutics so that they could bring this important device to market themselves.
Will your device work for all kids with aneurysms?
Not necessarily. Everyone's anatomy is unique, making a "one size fits all" solution hard to come by. That said, stents and other implants have the same challenge and are manufactured in a range of types and sizes so that they work for as many patients as possible. We plan to take a similar approach.
Does your device get rid of the aneurysm completely?
Hopefully! Our goal is to give the body a chance to heal itself, and then get out of the way. Because a device like this doesn't exist yet, it's impossible to know how complete a solution it may provide. Based on the encouraging clinical results of metal flow diverters (see Covidien's Pipeline® Embolization Device) and bioresorbable vascular scaffolds (such as Abbott's ABSORB®), we believe this device could be a game changer for kids with aneurysms. Even if our Bioresorbable Flow Diverter does not completely heal the aneurysm in all patients, it could help doctors extend and improve quality of life by delaying more aggressive treatments (such as surgery or traditional stenting) until the patient is fully grown. By dissolving away within 2-3 years, our device will give physicians more options to meet the needs of each individual child while avoiding traditional long-term complications.
Have you reviewed this technology with any Kawasaki Disease specialists?
We started by validating the concept with clinical pathologists who are very familiar with aneurysms, bioresorbable stents, and flow diverters, then sought additional input from the medical community, including a premier US KD expert, to strengthen the concept. An important piece to keep in mind is that the physician placing stents in the heart is generally different than the one placing metal flow diverters in the brain, who is different still from those doing these types of procedures in pediatrics, or the cardiologist specializing in KD. We recognize that developing this device will require a unique combination of medical disciplines and inputs from various experts, which is why we have consulted and will continue to call on a Scientific Advisory Board throughout the various stages of development. While attending the International Kawasaki Disease Symposium in February 2015, Aubry was able to connect directly with several more KD specialists who were eager to learn about the concept and hear results from some of the planned testing.
Based on your preliminary research, would your bioresorbable flow diverter be best suited to children who are in the earlier stages of their healing and have no early signs of stenosis?
Existing research suggests earlier is better. That said, Abbott's ABSORB and others are setting good clinical precedence for how to deal with stenosis, even in older patients with heavy calcification. Because patients with KD often have this combined issue (aneurysmal disease with stenoses at the necks), we think a dedicated design may be necessary that has separate zones to prop the vessel open at each end (similar to a stent), but resists expanding across the aneurysm where it is helping to define the new lumen for blood flow. This is one of the key reasons we need our flow model -- to do functional testing and figure out ways to optimize it. Definitely on our radar as a key design consideration. We're pulling together some deeper dive videos that touch on some of these points. Be sure to check back for updates. We will send out an announcement when these post to the website.
Will this device be able to help my child who has... Multiple Aneurysms? Stenosis at the Aneurysm necks? Has already undergone bypass surgery?
Candidly and simply put, it is too early to know. Given that these are common scenarios with the progression of Kawasaki Disease, our engineers are designing with each of them in mind. That said, these are all very different and complex clinical situations, and each child’s heart is unique. In the end, it will be up to each family and their cardiologist to decide the best course of treatment. Our goal is to add to the toolbox of solutions, and bring this technology forward, to the benefit of as many children as possible. To understand what a device like this is capable of, we need to perform a lot of bench testing in a variety of vascular models, which will help us refine the design and better understand the capabilities (and limitations) of this technology. That is why we are asking for help to fund the bench top flow model as a key next step in our development process. It is important to keep in mind that even once this device is in use, second and third generation designs will likely be developed to help treat aneurysms in a wider range of anatomies and clinical scenarios. This is a process that does take time, but we believe by starting it now instead of waiting (possibly years or even decades) for someone else to bring it forward, we are giving it the best possible odds of helping our children and sparing those who may be diagnosed in the future from some of the challenges we are forced to face as families of those affected by KD.