Revolutionary Noblestitch™ Approach Prevents Strokes Effectively

Noblestitch™ System Achieves Outstanding Stroke Prevention

A pivotal study led by Professor Dr. Achille Gaspardone unveiled remarkable findings about the Noblestitch™ suture-mediated Patent Foramen Ovale (PFO) closure system. The findings were shared at the TCT Congress, showcasing an impressive record of preventing recurrent strokes among patients with histories of PFO associated strokes.

Study Overview and Participant Details

The comprehensive evaluation involved 703 patients treated over several years. This extensive cohort, treated between 2016 and 2023, underwent meticulous assessment, highlighting the effectiveness of the Noblestitch™ system. Notably, during an average follow-up of four years, there were zero instances of recurrent strokes or transient ischemic attacks (TIAs), reinforcing the Noblestitch™ as a frontrunner in minimally invasive PFO closure solutions.

Key Findings from the Research

Among the striking outcomes of the study were the following:

• Efficacy Outcome: Across all 703 patients, the follow-up period revealed no recurrent strokes or TIAs.
• Safety Profile: The Noblestitch™ exhibited a commendable safety profile, without any complications related to suturing.
• Technical Success Rate: Impressively, the study demonstrated an 88% technical success rate within 12 months, linked with a nil occurrence of strokes or TIAs, regardless of technical closure rates.

Expert Comments on the Findings

Dr. Gaspardone remarked, "The suture-mediated PFO closure approach presents a reliable long-term solution. In our examined cohort, the clinical outcomes of this method surpassed those previously reported for conventional umbrella closure devices regarding the reduction of recurrent strokes and device-associated complications such as atrial fibrillation."

Adding to this, Dr. Anthony Nobles, President of Nobles Medical Technologies II, expressed, "This groundbreaking study confirmed no instances of strokes or TIAs in this extensive cohort with an average follow-up of four years. This stood in stark contrast to reported rates from studies on Gore Helix® and Amplatzer™ devices, which highlighted stroke rates of 4.7% and 3.6% and TIA rates of 3.4% and 1.4% respectively."

A Shifting Paradigm in PFO Closure

Dr. Gaspardone further stated, "This study encompasses the largest consecutive patient group to conclusively demonstrate the remarkable efficacy and safety of the Noblestitch™ for PFO closure. With a four-year average follow-up showing zero strokes and no complications in all 703 patients, this reinforces the stitch's position as the preferred choice for PFO closures."

The Noblestitch™ system symbolizes a groundbreaking strategy in tackling PFO closures, particularly highlighting the benefits of the 'Suture First' approach. This method not only emphasizes safety but also substantial long-term effectiveness, especially in patients with specific anatomical conditions favorable for closure.

The incorporation of the LASSO score further aids clinicians in predicting the success of closures, ensuring high rates of technical success and improved patient outcomes.

Conclusively, this study strongly supports that Noblestitch™ provides a dependable, device-free solution for PFO closure, establishing a new standard of care concerning safety and efficacy for patients suffering from cryptogenic strokes.

About Noblestitch™

Noblestitch™ is a cutting-edge suture-mediated cardiovascular technology crafted to address structural heart defects. It offers a minimally invasive alternative designed to reduce adverse events significantly while optimizing long-term health results.

The Noblestitch EL system holds FDA clearance in the USA and is CE Marked in the EU, specifically approved for cardiovascular suturing and PFO closure in European markets.

Frequently Asked Questions

What is the main benefit of Noblestitch™?

The primary advantage of Noblestitch™ is its effectiveness in preventing recurrent strokes among patients with PFO, evidenced by a four-year follow-up with zero recurrent events.

How many patients were involved in the study related to Noblestitch™?

703 patients were part of the comprehensive study assessing the efficacy of the Noblestitch™ system for PFO closure.

What does the "Suture First" approach refer to?

The "Suture First" approach is a technique emphasizing suture-mediated closure of PFO that demonstrates significant safety and efficacy advantages in achieving good outcomes.

Is Noblestitch™ FDA approved?

Yes, Noblestitch EL is FDA cleared in the USA and CE Marked in the EU for cardiovascular suturing, including PFO closure.

Who led the study on Noblestitch™?

The study was spearheaded by Professor Dr. Achille Gaspardone, who highlighted the impressive results during the TCT Congress presentation.

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