Dr. Pieter R Stella, MD, PhD the Head of Interventional Cardiology at the University Medical Center in Utrecht
expressed his views following his initial experience using the NobleStitch™ EL. “I was positively impressed with the use of the system and the good outcome we experienced in the first patients.” Dr. Stella is continuing to grow his experience with the NobleStitch™ EL and with Dr. Federico De Marco
who was an author and investigator on the Italian clinical study recently published in EuroIntervention, who proctored Dr. Stella’s initial cases and will be joining Dr. Stella for his upcoming NobleStitch™ EL cases.
Professor Anthony Nobles
, CEO and Inventor of the NobleStitch™ EL, noted, “The Netherlands
is a natural market for us. Having one of the best healthcare systems in the world, with a high standard for improving patient treatment and outcomes. Having the ability with our rapid growth to bring physicians together in proctoring our device is another validation of its success. The added collaboration supports our belief that with each new user there is an added affirmation of the devices ease of use and success in treatment. The results we are seeing both at the time of procedure and post procedural are reinforcing all the data we have been collecting over the past years which verifies the safety and efficacy which we believed in from the start. I also am excited to provide regular updates to the patients, physicians and our shareholders on the growth and benefits of the NobleStitch across the world.”
Read the recent data published in EuroIntervention showing the benefits of NobleStitch™ over traditional umbrella occluders, (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.html)
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. A PFO can also let deoxygenated blood and certain chemicals cross over to the arterial side. The presence of a PFO has been linked to a number of clinical issues, mainly strokes, migraines and chronic fatigue. Developments are being made to solidify the link between PFO and strokes or migraines, and to identify patients that would benefit from PFO closure.
About Nobles Medical Technologies II
Nobles Medical Technologies II, Inc.
was founded by Prof. Anthony Nobles
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 2)
. 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.
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.
manufactures and markets the NobleStitch™ EL under exclusive license from Nobles Medical Technologies II, Inc. NobleStitch™ EL is FDA cleared for vascular suturing in the United States
and CE Marked for cardiovascular suturing and PFO closure in the European Union and the Republic of Kazakhstan
For more on Nobles Medical Technologies II
View original content with multimedia:http://www.prnewswire.com/news-releases/noblestitch-el-continues-expansion-through-europe-with-sales-launch-in-the-netherlands-300658554.html
SOURCE Nobles Medical Technologies II, Inc.