Nobles Medical Technologies II, Inc. Launches NobleStitch™ EL Sales in Germany With Five Successful Cases
Prof. Horst Sievert Performs Multiple Closures
Frankfurt, Germany—June 8, 2016—Nobles Medical Technologies II, Inc. (NMT2) today announced that Prof. Dr. Horst Sievert of the Cardiovascular Center, Frankfurt successfully completed five PFO closures using the NobleStitch™ EL. This marks the official sales release of the NobleStitch™ EL in Germany.
The first cases were performed in Germany last year by Dr. Michael Mullen and Prof. Sievert—one a week before the CSI Frankfurt Congress, and the second a live cased performed during the congress itself. Subsequently, Prof. Sievert requested to use the NobleStitch™ EL on a series of patients with previous history of stroke, and evidence of septal defects. Eight patients were scheduled for the initial training and use of the NobleStitch™ EL. Three patients had Atrial Septal Defects (ASD) with little or no PFO tunnel detected. One of these was not a candidate for the NobleStitch™ EL and the remaining 2 were selected to close or reduce the ASD to use a smaller implant. The five PFO cases were all successfully closed, including one with an additional septal fenestration (an additional hole in the septal wall).
Prof. Anthony Nobles, CEO of NMT2 commented, “Prof. Sievert and his staff were exceptional. I have trained hundreds of cardiologists and never had someone respond so quickly to instruction and demonstrate such flawless technique within a couple cases. He has watched the evolution of the NobleStitch technology as it has been developed over the last few years, and I know from our conversations he found it intriguing. He certainly found this most recent version of the NobleStitch™ EL easier to use than the previous design. He even used the devices in some defects that would normally not be a candidate for this technology due to the lack of sufficient tunnel to close. But by maintaining the alternative of device closure as a back up, he was able to close two of these four unique cases with little to no shunt, and reduce the ASD in two others. It was an amazing day in the cath lab.”
Dr. Michael Mullen, Cardiologist St. Bartholomew’s Hospital, London, and member of the NMT2 clinical advisory board commented, “We continue to gain invaluable experience with each new physician performing cases, and we continue to broaden the patients we can treat with the NobleStitch™ EL. With this experience in Germany, we made two unexpected advances in the device and technique. We believe we have discovered how to make the device perform in certain patients with tough secundum septum, which can be found in some older patients. We have also determined a pathway to treating potential residual shunts, particularly in short PFO tunnels. I look forward to these continued advances that potentially allow us to treat even larger patient populations.”
Prof. Nobles also added, “Prof. Sievert and Dr. Mullen also provided excellent feedback that led us to our next development of the NobleStitch™ EL, which will allow us to treat shorter tunnels that would potentially have a residual shunt. We are implementing these in our next-generation NobleStitch™ ELP which will be released next month.”
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About Nobles Medical Technology II
Nobles Medical Technology II, Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the PFO, ASD-closure, and vascular-suturing marketplace. The company does business under the name of Nobles Medical II
(NMT II). Initial efforts of the company are focused on the innovative suture-based PFO closure system for closing the Patent Foramen Ovale (PFO), a tunnel between the right and left atria of the heart.
The NobleStitch™ is approved for PFO Closure and Cardiovascular suturing in the European Union. The NobleStitch™ EL is FDA cleared for vascular suturing in the United States. NobleStitch™ EL is distributed worldwide by HeartStitch®, Inc. (HeartStitch® is a registered trademark of HeartStitch, Inc.).
NobleStitch™ EL for PFO closure
Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.
For more on Nobles Medical Technologies II visit www.NoblesMedicalTechnology.com.