SOURCE: HeartStitch, Inc.

Heartstitch, Inc.

March 10, 2016 07:10 ET

First in Man -- First Ever Percutaneous Atrial Septal Defect (ASD) Closure and Atrial Septal Aneurysm (ASA) Repair Performed Without an Implantable Device Using the NobleStitch EL

LOS ANGELES, CA--(Marketwired - March 10, 2016) -   Dr. Niels Erik Nielsen, Director of Structural Heart Interventions at the Linkoping University Hospital in Linkoping Sweden, successfully performed the first ever percutaneous ASD closure and ASA repair and remodeling without the use of an implantable device. Dr. Nielsen also successfully closed a PFO in the 38-year-old patient, making this the first patient to receive treatment for all 3 heart defects using 2 NobleStitch EL sutures. Dr. Nielsen also successfully performed 2 more subsequent PFO closures using the NobleStitch EL suture based PFO closure system.

http://noblesmedicaltechnology.com/Library/noblestitch.html

Dr. N.E. Nielsen performed This First-In-Man case on a patient that would otherwise require a very large metal umbrella device or open heart surgery. Dr. Nielsen commented, "I hesitate to recommend closure of a PFO with traditional 'umbrella' type implants due to the potential for long and short term complications that can arise from placing large metal structures in the heart, particularly in this patient where we would close the ASD, the likelihood of closing both the PFO and the ASD with a traditional single umbrella implant would be unlikely. Furthermore, the ASA would complicate closing with the umbrella. The NobleStitch provided an alternative with the opportunity of closing both defects and without introducing any of the known risks of the metal implants."

Dr. Nielsen further commented, "This was the first time we used the NobleStitch cardiovascular suturing device in this way. We suspected that the patient, apart from the PFO, also had a small ASD, which was verified during intervention. We started by attempting to cross the PFO, but the ASA made accessing the PFO impossible. Instead we crossed the ASD located in the ASA. Prof. Nobles was consulting during the case to determine the viability to use the NobleStitch in these circumstances, and we elected to suture the ASD and collect enough of the septal tissue to remodel the ASA back to its almost normal structure. After this we were able to access the PFO and close it with a second NobleStitch EL. The NobleStitch allowed us to address these three structural heart abnormalities successfully without implantation of an umbrella, and without the inherent risks of having such a device (arrhythmia, embolization, late erosion)." 

Dr. Baranowski who performed the case with Dr. Nielsen provided a valuable evaluation of the anatomy with intra-cardiac echocardiography on performing the case. The collaborative effort based on their collective experience over the last 2 years using the NobleStitch was essential to planning the approach.

Professor Anthony Nobles, CEO of HeartStitch who consulted on the case, stated, "The NobleStitch EL was designed for cases like this. PFO closure is one of the many cardiovascular structure the NobleStitch EL can be used to suture. I was very pleased to see the NobleStitch EL provide this patient a safe alternative to open heart surgery or implanting a very large metal implant. Any First-In-Man is significant for a product and for the future of structural heart interventions. We look forward to expanding the number of cardiovascular suture repairs performed using the NobleStitch El." 

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 10%-25% 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 tunnel 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 tunnel eventually closes completely within the first few months.

However, in some patients, the foramen ovale fails to seal and stays "patent." In patients with a Patent Foramen Ovale (PFO), the tunnel 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 to cross over to the arterial side. The presence of a PFO has been linked to a number of clinical issues, mainly stokes, 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 Atrial Septal Aneurysm

Atrial septal aneurysm is a congenital cardiac abnormality that is characterized by saccular formation of the interatrial septum. Redundant atrial septal tissue results in bulging of the septum into either or both atria during the cardiac cycle.

http://www.medscape.com/viewarticle/704107_3

About Nobles Medical Technologies II

Nobles Medical Technologies II, Inc. was founded to leveraging its technologies in the PFO and ASD closure 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

Contact Information

  • For more information, please contact shareholder representatives:

    Dru Dobbs
    P. +1 714 427 6348
    F. +1 714 427 6343
    ddobbs@nmt2.net