During transcatheter aortic valve replacements (TAVR), there is a risk of cerebrovascular events due to embolic debris breaking off from vessel walls and migrating to the brain. While microembolization during the procedure is a universal phenomenon, the majority of patients experience no symptoms. However, a clinically-evident stroke is a serious and feared complication.
Protembis is developing a solution that will hopefully reduce the incidence of post-TAVR cerebrovascular events. The Aachen, Germany-based company’s ProtEmbo device is an embolic protection filter designed for placement in the aortic arch, at the base of the three large vessels leading to the brain. The filter is placed via the left radial artery before the TAVR procedure begins and removed at its conclusion.
We asked the founders and Co-CEOs Conrad Rasmus and Karl von Mangoldt about their company and ProtEmbo.
Cici Zhou, Medgadget: Tell us how Protembis started. What was the inspiration behind the company and ProtEmbo?
Protembis: Our company Protembis was founded based on the vision to provide a simple solution to protect patients undergoing transcatheter aortic valve replacement (TAVR) from the risk of suffering a stroke. One of the co-founders is an interventional cardiologist who had seen stroke occur during these procedures and as a result of it looked more carefully at his patients’ brains pre- and post-procedure. What he saw convinced him that cerebral protection is absolutely necessary for better patient outcomes after these procedures. We have built a team of great people with clinical, technical, regulatory and business backgrounds to bring this idea to reality. What began as a drawing on a napkin soon became a patent application and today a fully functional medical device at clinical investigation stage.
Medgadget: What is the ProtEmbo made of? Does it affect blood flow through the aortic arch vessels?
Protembis: The ProtEmbo System is a temporary use, intra-aortic embolic protection filter device for single use, implantable as an adjunctive device at the beginning of a TAVR procedure and removed following the completion of the procedure. The ProtEmbo System comprises a filter which is connected to a delivery unit enabling delivery of the unexpanded device via a catheter and placement in the aortic arch of a patient. The filter consists of a porous polymeric material with 60µm pores that allows free passage of blood cells but blocks critical embolic particles from entering the three side branch vessels leading to the brain.
In our first-in-human study we observed a very positive effect of ProtEmbo on patient’s brains with a reduction of circa 50% in brain lesion burden compared to patients without cerebral protection. When adjusting for pre-procedural lesion burden the ProtEmbo showed an up to 90% reduction.
Medgadget: How does usage of the ProtEmbo affect the surgery workflow or introduce any additional surgical risks?
Protembis: The ProtEmbo System is a very intuitive adjunct device to be used during TAVR. It can be delivered through a commercially available 6F sheath via the left arm of a patient. The vascular access for ProtEmbo can be conducted while the patient is being prepared for TAVR. The ProtEmbo vascular access is isolated from all other interventional equipment, leaving especially the groin femoral access free for any kind of combined interventional procedures. Placement of the filter is extremely quick and easy, adding no significant time to the overall procedure. Also, using the left radial access entails fewer risks such as bleeding and use of additional closure devices.
Medgadget: At what stage is the company today?
Protembis: Today, Protembis has a team of 10+ people and is preparing a European clinical study with its next generation ProtEmbo System. The most recent funding was completed in late 2018 with a $10 million Series A financing round. A syndicate consisting of VCs, family offices and medtech angel investors together with US medtech company Abiomed Inc. had invested back then. This last funding round secures the next steps through CE marking of the ProtEmbo System.
Medgadget: What are some of the biggest challenges facing the team over the next few years?
Protembis: The biggest challenge for us – as for any medtech startup at a comparable stage – is certainly the transition to Medical Devices Regulation (MDR). We at Protembis have taken the strategic decision not to attempt slipping through under Medical Device Directive (MDD) but to undergo the conformity assessment for our product under MDR. This entails additional hurdles but we see this as a competitive advantage for our company. MDR brings requirements closer to FDA standard and will increase confidence in our products. Following CE mark approval, Protembis plans to conduct a larger clinical trial in the United States for FDA approval of the ProtEmbo.
Check out this video on how ProtEmbo works:
Link: Protembis homepage…