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MedTech Outlook | Friday, September 13, 2019
The device will enable the closure of Patent Foramen Ovale, thus reducing the risk of strokes in patients.
FREMONT, CA: The US Food and Drug Administration (FDA) recently granted approval to Nobles Medical Technologies II to conduct its prospective pivotal clinical trial named STITCH for the expanded indication of Patent Foramen Ovale (PFO) Closure for Reduction of Recurrent Ischemic Stroke. The NobleStitch EL was cleared for the indication of cardiovascular suturing in April 2017 and CE mark in Europe for PFO closure in 2012 and has been available since 2015.
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The study will potentially provide the essential data to expand the indication in the United States to include PFO Closure for the Reduction of Recurrent Ischemic Stroke. The NobleStitch EL medical device places a suture into the atrial septal walls, also called the septum primum and the septum secundum, and ties them closes with a small implantable polypropylene knot located in the right atrium, leaving nothing in the left atrium.
The STITCH is a comparative trial, with the primary endpoints comparing the safety and effectiveness of the NobleStitch EL suture-based closure system for PFO closure to the FDA approved Amplatzer PFO Occluder from Abbott Laboratories, a metal umbrella type implant placed in the left and right atrium. The primary endpoints of STITCH will look at the closure rates and safety events at six months follow-up for the two devices before submission of the data for approval of the NobleStitch EL device for the new indication.
Nobles Medical Technologies II expects to begin the enrollment of patients as early as October 2019, at its first US center in Virginia with Dr. Jim Thompson, the Principal Investigator for the trial. PFO closure is a crucial part of structural heart treatment, and the study will facilitate invaluable data regarding the devices. The clinical study marks a significant milestone for the company, with an investment of almost two years on the IDE.
Founded by Prof. Anthony Nobles, Ph.D., Nobles Medical Technology leverages its technologies in the PFO, ASD-closure, and cardiovascular-suturing for enhancing the living of the patients. Its initial efforts have been focused on developing an innovative suture-based PFO closure system for closing the PFO. Its NobelStitch EL device is approved by the FDA for vascular and cardiovascular suturing in the United States.
PFO is characterized by an unsealed tunnel between the right and left atria of the heart. The heart defect is relatively common, with people up to 38 percent suffering from the condition. However, it is considered benign in most cases. The PFO is formed as a trace of fetal circulation. The link between the right and left atria are created when the chambers of the human heart begin to develop. The connection allows blood to flow directly from the venous circulation to the arterial circulation, circumventing the non-functioning fetal lungs.
The pressure differential between the right and left atria changes after birth, resulting in operational blood flow to the fully functioning lungs, due to which, the communication tends to close entirely within the first few months. Also, in some patients, the foramen ovale might fail to seal. In such patients, the communication can reopen under elevated atrial pressure, including from coughing and straining.
PFO poses a problem when it gives a pathway for blood clots to pass directly into the arterial circulation without being filtered out by the capillary bed of the lungs. In many cases, the presence of the PFO has also been attributed to strokes and transient ischemic attack (TIA). The recent pivotal trials, including RESPECT, REDUCE, and CLOSE, have demonstrated the role of PFO closures in the reduction of the risk of recurrent ischemic strokes.
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