Two Year Data Leaves Direct Flow Medical® Pumped Up About TAVI Outcomes

Excellent patient outcomes with few complications, is the conclusion from two year data from the DISCOVER CE Mark Trial into the Direct Flow Medical® Transcatheter Aortic Valve System, presented at the EuroPCR conference in Paris, France.

Background

The most novel of the different approaches to transcatheter aortic valve implantation, the fully repositionable and retrievable Direct Flow Medical system is indicated to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural aortic regurgitation (AR), a strong predictor of long-term mortality.

Direct Flow’s system addresses the regurgitation concern by sealing the annulus and enabling complete assessment of hemodynamic performance with “in situ” repositioning of the valve after full deployment.

Two year data were presented by Antonio Colombo, MD, PhD, from the Ospedale San Raffaele in Milan, Italy. The fully repositionable and retrievable Direct Flow Medical system is indicated to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural AR, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with “in situ” repositioning of the valve after full deployment.

Two year data from the DISCOVER CE Mark Trial were presented by Antonio Colombo, MD, PhD, from the Ospedale San Raffaele in Milan, Italy. The trial is a prospective, multi-center study conducted at nine European sites of 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair. Results demonstrated an 80 percent survival rate at 24 months, continuing the positive trend showing 90 percent survival after one year and 99 percent after 30 days. All patients experienced mild or less post-procedural aortic regurgitation (AR), with 85 percent having none or trace AR. The mean gradient remained stable at 12.4mmHg at 24 months, compared to 12.6mmHg at 30 days. At the two year mark, 92 percent of patients had improved by more than one New York Heart Association (NYHA) functional class, improving upon the 83 percent of patients that had improved by more than one New York Heart Association (NYHA) functional class at 30 days. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory and were sustained over time.

Investigator comments

“The 24 month DISCOVER results demonstrate that the initial clinical improvements seen with the Direct Flow Medical valve translate into exceptional long-term outcomes,” said Dr. Colombo. “This next generation TAVI device is the first to report such outstanding results treating an extremely sick patient population.”

Source: Direct Flow Medical, Inc.

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