By AMANDA PEDERSEN
Medical Device Daily Senior Staff Writer
The market for percutaneous catheter-based heart procedures such as transcatheter aortic valve replacement (TAVR) has been developing at a rapid pace, but vascular access and closure devices have not been able to keep up.
Interventional cardiologists currently have to rely on a vascular surgeon to create a surgical cut-down to provide access and again at the end of the procedure to provide closure.
To address this need, some smaller companies are cropping up with access and/or closure products designed specifically for TAVR and related procedures. One such company is Micro Interventional Devices (MID; Bethlehem, Pennsylvania), which reported today that it has closed on a $500,000 bridge financing to advance the clinical development of its lead technology, Permaseal. MID was founded about two years ago.
Life Sciences Greenhouse of Central Pennsylvania (LSGPA) joined current investors Batelle Ventures and New Hope Ventures in the bridge round.
"That $500,000 will take us into the clinic and help us raise our Series B financing," Michael Whitman, president/CEO of MID, told Medical Device Daily.
The proceeds of this financing are expected to push MID into the first-in-man clinical trial phase with a 40-patient study (STASIS) in Europe planned to kick off this year during the third quarter. The company says it expects to report top-line data from the trial as early as the fourth quarter.
"The bridge financing is a key step in the accelerated development of MID and Permaseal as it will enable us to proceed with the first-in-man study of what we believe could become the standard of care for structural heart repair access and closure," Whitman said.
According to the company, Permaseal is the first transapical access device to enable true "self-sealing," sutureless cardiac access and closure. The technology combines soft tissue anchors and advanced biocompatible elastomers that form a "web" around the myocardial access site. The device is applied to the myocardium prior to the procedure and provides hemostatic access to the left ventricle during minimally invasive cardiac procedures.
Once the procedure is completed and the cannula and guide wire are extracted, the Permaseal webbing constricts around the opening in the heart, providing instantaneous closure while allowing for flexibility to accommodate a beating heart. Permaseal is designed for a range of structural heart repair procedures including transcatheter aortic valve implantation (TAVI), transcatheter mitral valve replacement and mitral valve repair.
Whitman said development of Permaseal was directly inspired by the need to improve TAVI outcomes due to complications related primarily to the cut-down part of the procedure. "With Permaseal, MID believes it possesses the only truly self-sealing, sutureless transapical access device, and we look forward to the initiation of the STASIS trial and subsequent data as evidence of its value," he said.
Designed as a non-randomized, multi-center, CE-mark study, STASIS (Sutureless Transcapial Access and Closure Study) will evaluate the safety and performance of Permaseal for left ventricular transapical access and closure, with procedure time serving as a secondary endpoint. The study will seek to enroll 40 patients at five sites within the European Union (EU).
Rüdiger Lange, MD, director of the department of cardiovascular surgery of the German Heart Center (Munich, Germany), and principal investigator for the STASIS trial, remarked, "Reliable access and closure that allows for a minimally invasive transapical approach is key to improving the efficiency and reproducibility of structural heart repair surgery. Doing so offers the potential to reduce OR time, reduce blood loss and help to simplify what today can be complex procedures. I welcome the opportunity to lead the STASIS trial and play a role in the development of what could become an important contribution in transapical structural heart repair surgery."
Permaseal will initially be utilized in patients with aortic stenosis undergoing TAVI procedures; however, the device is expected to have indications in most structural heart disease procedures, including those related to mitral valve disease, Whitman told MDD.
Currently, there are more than 830,000 people suffering from aortic stenosis in the U.S., with roughly 50% of TAVI patients being treated with the transapical approach, the company noted.
In recognition of the potential that Permaseal offers to the cardiovascular industry, MID was selected to present at EuroPCR 2012 next week in Paris.
Willard Hennemann, PhD, chief science officer and EVP, plans to discuss the latest histology results from MID's pivotal animal study along with the clinical protocol for the STASIS trial during the conference's "Cardiovascular Innovation Pipeline - Enabling TAVI" session.
So far, physicians have showed considerable interest in the new product, Whitman said. "They believe that they're going to have a much smaller footprint on the heart," by using Permaseal.
Another small company trying to solve the access-closure problem for physicians performing TAVI procedures is VasoStitch (Danville, California). The VasoStitch system is actually designed to provide the access replicating what the vascular surgeon does by providing a cut-down incision into the femoral artery and then makes the closure part of the procedure much more straight forward. The system is designed to reduce procedural complexity and eliminate the need for an "open" surgical procedure (Medical Device Daily, April 13, 2012).
Published May 9, 2012