Prof. Dr. Gaspardone, who has been utilizing the NobleStitch™ EL at his center for over 18 months as well as proctoring physicians across Italy with the revolutionary NobleStitch EL is the first physician to perform more than 150 cases. Prof. Gaspardone has adopted the NobleStitch as his first choice for performing PFO closure.
Prof. Gaspardone was the lead investigator in the recently peer reviewed journal publication of a 200 patient multi-center trial in EuroIntervention that demonstrated equivalent closure rates to the large umbrella devices and a greater safety profile (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.html).
The continued success of the NobleStitch™ has generated a waiting list of patients who are requesting closure with the suture system in the Rome center and across Italy.
Prof. Gaspardone commented, “As a physician I am always exploring new technologies that can bring safer and more effective outcomes for my patients, having performed more than 1000 occluder cases over the past decades I was excited to learn about the NobleStitch™, which provides many advantages over the conventional umbrella occluders. I immediately adopted the NobleStitch™ after a few cases when I realized how simple and intuitive the technology was. There is a learning curve to the technique of the device, however I felt it was quickly mastered and the consistent ease of use and outstanding outcome of each case makes the NobleStitch™ my first choice every time.”
Dru Dobbs, the VP of Manufacturing for HeartStitch®, Inc. which manufactures and distributes the devices on behalf of Nobles Medical Technologies II, Inc. commented, “As we see Prof Dr. Gaspardone achieve such as great milestone utilizing our product, it demonstrates why the NobleStitch™ suture system continues to penetrate the marketplace, and why we have seen such a continued growth in physician acceptance. We at HeartStitch® have seen the dramatic effect of this rapid market growth and have been scaling manufacturing to meet the growing worldwide demand. We will continue to provide physicians with the ability to provide the best option for their patients who suffer from cryptogenic ischemic stroke, severe migraines, platypnea-Orthodeoxia and other PFO related disease states.”
Professor Anthony Nobles, Inventor of the NobleStitch™ EL and Chairman, CEO and Chief Clinical Officer of HeartStitch®, Inc. stated, “This is a significant milestone in the expansion of the NobleStitch throughout Europe. It has been a great pleasure working with Prof. Gaspardone who has been a proponent of the NobleStitch and contributor to the evolution of the simplified procedural technique now used across Europe and around the world. By performing more than 150 cases with the NobleStitch Prof. Gaspardone has provided post market data and recommendations that have been essential to the engineers and staff of our Company.”
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.