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PHONE HOTLINE: +41 34 448 14 14E-MAIL: info@mcm-medsys.ch
PHONE HOTLINE: +41 34 448 14 14E-MAIL: info@mcm-medsys.ch

NobleStitch™ EL

NobleStitch™ EL

Designed to provide the most intuitive, least invasive solution for vascular and cardiovascular procedures: Noblestitch™ EL is a percutaneous suturing system for PFO closure. Both sides of the channel are pulled together with two polypropylene threads and then closed with a knot. This technique prevents recurrent strokes in patients diagnosed with persistent foramen ovale.  

How it works 

The system consists of two suture devices and a knot placement device (KwiKnot™). With these three catheters, PFO closure is performed in three steps: 

  1. Noblestitch™ EL ‘S’ places the first suture through the septum secundum.
  2. Noblestitch™ EL ‘P’ places the second suture through the septum primum.
  3. KwiKnot™ closes the PFO by pulling the septa together and locking the sutures in place. 
Why NobleStitch™ EL? 

In approximately 27 % to 38 % of people, the small open channel between the right and left atrium of the heart does not close on its own after birth. This is condition is called persistent foramen ovale (PFO). In some people, PFO can trigger a stroke due to blood clots entering the left-sided heart cavities and traveling to the brain. Suture-mediated closure with NobleStitch™ EL protects patients who have previously suffered from such a stroke against recurrent incidents.  

  • During the procedure, no sheath passes through the PFO and ends on the left side of the heart (which would promote air embolisms).
  • After the procedure, no foreign body remains on the left side of the heart (which might lead to clot formation, trigger atrial fibrillation, or injure adjacent structures such as the aorta).
  • The whole procedure is painless and takes about 30 minutes.
  • Patients can return home the next day.  
Publications
Report from Italian registry 2018

“The early results of this first Italian registry indicate that the suture-mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, and provides an effective closure of PFO comparable to traditional devices with a good safety profile at medium-term follow-up.” 

Gaspardone et al. EuroIntervention 2018. DOI: 10.4244/EIJ-D-18-00023  

4-year cohort study 2024

“This is the largest cohort of consecutive patients to definitively show the extraordinary efficacy and safety of the NobleStitch™ for PFO closure. With a 4-year mean follow up of zero strokes and no device related complications in 703 consecutive patients this affirms the stitch as the first choice for PFO closure." 

HeartStitch® Inc. Article published online. PR Newswire 2024.