Protaryx Medical, a company based in Baltimore, Maryland, has developed a device to allow for more precise transseptal access to the left atrium during transcatheter procedures. The device provides three-dimensional control and steerability to take the guesswork out of transseptal access to the left atrium, and the company believes that this could improve physician convenience and reduce the chances of complications during such procedures.
Transseptal access to the left atrium is required during several transcatheter procedures, including repair or replacement of mitral valves, catheter ablation therapy, and closure of the left atrial appendage. However, to date, there hasn’t been a reliable and reproducible way to cross the septum, and the usual technique is time-consuming, difficult to master, and involves some guesswork.
This new device aims to make such access easier and more predictable. Protaryx recently announced receiving funding to further develop the device, including $5.1 M from Ajax Health, a medtech investor.
Medgadget had the opportunity to talk with Terri Burke, CEO of Protaryx Medical, about the technology.
Conn Hastings, Medgadget: Please give us an overview of the procedures that involve transseptal access of the left heart.
Terri Burke, Protaryx: Increasingly, more heart procedures are moving from open heart surgery to a minimally invasive approach, which includes catheter-based interventions on a beating heart.
Catheter-based procedures that require transseptal access include mitral valve repair and replacements, left atrial appendage closure and ablations for cardiac arrhythmias.
Medgadget: What challenges does transcatheter access of the left heart pose for clinicians at present?
Terri Burke: My co-founder Dr. Jim Gammie, a professor and chief of cardiac surgery at the University of Maryland, thinks deeply about how best to help patients and physicians. As he was performing beating heart, catheter-based mitral valve repair as an early adopter, he questioned why transseptal access was so difficult to master and had such a substantial learning curve.
Transseptal access requires clinicians to cross the fossa ovalis which is about the size of a quarter. Physicians will often tell us that this part of a procedure is referred to as the ‘great unknown’. Without precise control and steerability, physicians are less clear about where they will cross and how quickly they will cross. We’ve heard that this is problematic for physicians because they’d rather have a reliable, reproducible procedure that allows them to move forward with streamlined therapeutic delivery.
Medgadget: Can these challenges lead to complications and suboptimal outcomes for patients?
Terri Burke: Longer procedure times may increase complications for patients. By streamlining this part of the procedure, we believe it may be possible to help reduce potential complications and improve outcomes for patients.
Medgadget: Please give us an overview of the Protaryx device and how it works.
Terri Burke: The idea for the device came from Jim, who is a serial entrepreneur and the inventor of the Harpoon Medical device that was acquired by Edwards in 2017. We met when I was leading global marketing and business development for the heart valve business unit at Edwards and leading the structured acquisition of Harpoon Medical.
Jim felt that the ability to steer independently with three-dimensional control to pinpoint transseptal access was missing. By decoupling the catheter movements in three planes, our device is intended to provide a level of control and precision by creating more predictable access to the left heart.
The device is designed to provide a stable platform and unique articulation point located in the right atrium to create true, three-dimensional control and a reliable crossing of the fossa ovalis, a small area of the septum.
Medgadget: How does the device help to simplify transseptal left heart access?
Terri Burke: We have a number of features with our device that we believe will enhance the safety of the procedure including a unique atraumatic tip to provide tenting on the fossa ovalis that can help optimize transseptal access to the left atrium of the heart.
Medgadget: When will the device be available?
Terri Burke: We anticipate the device may be available in late 2021 – early 2022. The recent Series A funding from Ajax Health, with continued support from the University of Maryland Ventures, will be used to advance the development of the device.
Medgadget: What inspired you to get involved in this area?
Terri Burke: I always enjoy working in areas that have unmet clinical needs. I find these areas can benefit from approaching the problem from a new direction. When Jim and I first discussed his concept, I was intrigued by the opportunity to innovate upon an important procedural step that had not seen a transformative change in over 40 years. To be able to improve this step for patients undergoing beating-heart interventions and create an overall experience that could potentially improve their outcomes is a great privilege.
Medgadget: Was it challenging to minimize the device for catheter delivery and deployment?
Terri Burke: The state of Maryland ecosystem supports innovation by providing early funding, which allows for rapid prototyping and learning. We had the benefit of several grants from Tedco and University of Maryland Ventures to support our feasibility work, so we were able to refine the earliest concepts to quickly develop a viable catheter system. Part of this rapid iteration included reducing the profile of the device and solidifying the important design features.
Link: Protaryx Medical…