Healthcare Industry News: Transcatheter Mitral Valve Replacement
News Release - May 9, 2012
Micro Interventional Devices, Inc. Secures Bridge Financing to Advance Clinical Development of Permaseal(TM)Proceeds to Fund Initiation of First-in-Man Clinical Study of Company's Self-Sealing, Sutureless Cardiac Access and Closure Technology
Permaseal to be Featured during the "Cardiovascular Innovation Pipeline- Enabling TAVI" Session at EuroPCR 2012
BETHLEHEM, Pa., May 9, 2012 -- (Healthcare Sales & Marketing Network) -- Micro Interventional Devices, Inc.™ (MID), an emerging cardiovascular medical device company, announced today the close of $500,000 in bridge financing to advance the clinical development of the company's lead technology, Permaseal™. MID expects to initiate the 40-patient trial (STASIS) in Europe in the third quarter of 2012 with top-line data available by Q4 2012.
"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," stated Michael Whitman, President and CEO of MID. "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. Published data indicate that the percentage of transapical TAVI procedures is currently 50 percent. The emergence of next-generation access and closure devices, such as Permaseal, could propel this percentage even higher."
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.
Mr. Whitman continued, "There is growing need for safer, more efficient cardiac access and closure devices as procedures such as TAVI become more widespread. 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."
Designed as a non-randomized, multi-center, CE-Mark study, STASIS (Sutureless Transapical 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).
Professor Dr. med. Rudiger Lange, Director of the Department of Cardiovascular Surgery of The German Heart Center in 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."
In recognition of the potential that Permaseal offers to the cardiovascular industry, MID was selected to present at EuroPCR 2012 on May 17, 2012 in Paris, France. Willard Hennemann, PhD, Chief Science Officer and Executive Vice President, will 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.
About Micro Interventional Diagnostics, Inc:
Micro Interventional Devices, Inc. (MID) is an emerging cardiovascular medical device company founded in May 2010. MID is developing solutions for structural heart repair procedures, including transcatheter aortic valve implantation (TAVI), Transcatheter Mitral Valve Replacement, LVAD placement, mitral valve repair, valvuloplasty, aortic arch repair, ASD and VSD closure, left atrial appendage closure, ablation of arrhythmia and other emerging structural heart repair procedures. The company is developing proprietary technology based on a breakthrough in soft-tissue anchoring and associated delivery devices that enable off-pump procedures. To learn more, please visit www.microinterventional.com.
Source: Micro Interventional Devices
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