Structural heart focused HeartStitch said today its NobleStitch EL device was used to repair 3 patients with patent forman ovale heart defects in Astana, Kazakhstan.
A patent foramen ovale is a congenital heart disease in which hole in the heart that normally seals at birth remains open, and can lead to severe migraines, visual auras and stroke, the company said.
The procedures were performed by Dr. Michael Mullen and guided by Anthony Nobles at the National Research Cardiac Surgery Center in Astana, according to the company.
“We are gratified that our colleagues from abroad have brought this technology to Kazakhstan. We now have the ability to perform these important, minimally invasive procedures and thank Dr. Mullen and professor Nobles, who invented this innovative solution for cardiologists. We can now treat the Kazakhstani people using this practice,” attending surgeon Dr. Saule Kadirova said in a press release.
The NobleStitch EL device closes the hole through a minimally invasive cardiovascular suturing procedure, the company said, with a routine cardiac catheterization procedure to secure the closure.
“Working with such talented physicians makes the training of our NobleStitch technology more effective. Working with cardiology centers like NRCSC allows us to provide safe alternatives for PFO closure. It is gratifying for me to bring our latest technological breakthrough to Kazakhstan. Clinical successes as we have had here in Astana are the driving force for our continued growth worldwide,” Nobles said in prepared remarks.
Other companies have struggled to produce devices to manage PFO closures without complications. In November 2012, W.L. Gore & Associates researchers defended St. Jude Medical’s (NYSE:STJ) failed patent foramen closure device study, arguing that, although the study failed to meet its clinical endpoints it highlighted the need for better patient inclusion criteria.
NMT Medical ran aground after a clinical trial of its StarFlex implant for treating PFO failed to show that it could prevent recurrent stroke and transient ischemic attack. W.L. Gore later bought bankrupt NMT’s assets at auction.
The post HeartStitch touts new PFO closure method appeared first on MassDevice.
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