NOBLES MEDICAL TECHNOLOGIES II, INC. (NMT2) ANNOUNCED TODAY THE APPROVAL BY THE U.S. FDA OF ITS IDE OF NOBLESTITCH™ EL FOR PFO CLOSURE FOR REDUCTION OF RECURRENT ISCHEMIC STROKE
FOUNTAIN VALLEY, Calif., Sept. 5, 2019 /PRNewswire/ — Nobles Medical Technologies II has received approval from the U.S. Food and Drug Administration (USFDA) to conduct a prospective pivotal clinical trial called “STITCH” for the expanded indication of PFO Closure for Reduction of Recurrent Ischemic Stroke.
The NobleStitch™ EL was cleared for the indication for cardiovascular suturing in April 2017 and CE marked in Europe for PFO closure in 2012, where it has been available since 2015. This study is intended to provide the data to expand the indication in the United States to include “PFO Closure for the Reduction of Recurrent Ischemic Stroke”.
The NobleStitch™ EL is a medical device that places a suture into the 2 atrial septal walls (the septum primum and the septum secundum) and ties them closed with a small implantable polypropylene knot which is located in the right atrium leaving nothing in the left atrium.
The clinical trial is a comparative trial which the primary endpoints will compare the safety and effectiveness of the NobleStitch™ EL suture-based closure system for PFO closure to the FDA approved Amplatzer™ PFO Occluder (Abbott Laboratories) which is a metal umbrella type implant placed in the left and right atrium. The primary endpoints of STITCH will look at closure rates and safety events at 6 months follow-up for the 2 devices prior to submission of the data for approval of the the NobleStitch™ EL device for the new indication.
The Company expects to start enrolling patients as early as October 2019 at its first US center in Virginia with Dr. Jim Thompson who is the Principal Investigator for trial. Dr. Thompson stated, “I have not been this excited since medical school. PFO closure is an important part of structural heart treatment and this study will provide invaluable data about both devices.”
Prof. Dr. Anthony Nobles, Chairman and CEO of Nobles Medical Technologies II stated, “This is an important milestone for our company and our technology. Our team has worked for more than 2 years on this IDE.”
For further information regarding the trial please contact Nobles Medical Technologies II at info@noblesmed2.com or (714) 427-0398.
About PFO Closure
A PFO is a relatively common heart defect characterized by an unsealed tunnel between the right and left atria of the heart. This defect has been known to be present in anywhere between 27%-38% of people. However, in a number of cases, it is benign.
The PFO is formed as a trace of the fetal circulation. When the chambers of a human heart begin to develop, a communication is made between the right and left atria, allowing blood to flow directly from the venous circulation to the arterial circulation, circumventing the non-functioning fetal lungs. Following birth, the pressure differential between the right and left atria changes with newly operational blood flow to the fully functioning lungs. Because of this, the communication eventually closes completely within the first few months.
However, in some patients, the foramen ovale fails to seal and remains “patent”. In patients with a Patent Foramen Ovale (PFO), the communication can reopen under elevated atrial pressure, such as coughing, or straining.
A key issue with PFO is that it gives a pathway for blood clots to pass directly to the arterial circulation without being filtered out by the capillary bed of the lungs. The presence of a PFO has been linked to strokes and TIA (Transient Ischemic Attack). Recent Pivotal trials (RESPECT, REDUCE and CLOSE) have demonstrated that PFO closure reduces the risk of recurrent ischemic strokes.
About Nobles Medical Technology II
Nobles Medical Technology II, Inc. was founded by Prof. Anthony Nobles, PhD with the intent of leveraging its technologies in the PFO, ASD-closure, and cardiovascular-suturing marketplace. The company does business under the name of Nobles Medical II (NMT II). Initial efforts of the company have been focused in Europe 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 and cardiovascular suturing in the United States.
The NobleStitch™ is approved for PFO Closure and Cardiovascular suturing in the European Union.
The NobleStitch™ EL is FDA cleared for Vascular and Cardiovascular suturing in the United States. Further information including warnings and precautions can be found in the instructions for use.
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.
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SOURCE Nobles Medical Technologies II, Inc.
