July 28, 2014 7:57 PM ET

Healthcare Equipment and Supplies

Company Overview of Direct Flow Medical, Inc.

Company Overview

Direct Flow Medical, Inc. designs and develops medical implants used in the treatment of aortic and heart valve diseases. The company offers direct flow medical percutaneous aortic valve, which serves as a surgical valve while incorporating the desirable attributes for transcatheter delivery with the additional ability to be positioned, repositioned, and retrieved if necessary and a delivery system that includes a prosthesis attached to three position-fill lumens for positioning and aligning the prosthesis, as well as loaded into the delivery system. Additionally, it provides inflation media, a biocompatible two-part system that supports the structure of the implant. Direct Flow Medical, Inc...

451 Aviation Boulevard

Suite 107 A

Santa Rosa, CA 95403

United States

Founded in 2004

Phone:

707-576-0420

Fax:

707-576-0430

Key Executives for Direct Flow Medical, Inc.

Chief Executive Officer
Co-Founder
Vice President of Finance
Chief Medical Officer
Chief Development Officer
Age: 46
Compensation as of Fiscal Year 2014.

Direct Flow Medical, Inc. Key Developments

Direct Flow Medical, Inc. Presents at 2014 Wells Fargo Healthcare Conference, Jun-17-2014 11:10 AM

Direct Flow Medical, Inc. Presents at 2014 Wells Fargo Healthcare Conference, Jun-17-2014 11:10 AM. Venue: InterContinental Hotel Boston, 510 Atlantic Avenu, Boston, MA 02210, United States.

Direct Flow Medical, Inc. Announces 12 Month Outcomes from DISCOVER CE Mark Trial

Direct Flow Medical, Inc. announced 12 month outcomes from the DISCOVER CE Mark Trial. In the trial, a 90% survival rate was reported, continuing the initial positive trend of 99% survival after 30 days. Patients were treated with the Direct Flow Medical(R) Transcatheter Aortic Valve System and experienced excellent overall hemodynamic results, as well as a low rate of procedural complications. At 12 months, 100% of patients experienced mild or less aortic regurgitation (AR), with 77% having none or trace AR. The DISCOVER Trial 12 month outcomes were presented by principal investigator Joaquim Schofer, MD, from the Medical Care Center, Hamburg, Germany. The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at high or 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 unlimited repositioning of the valve after full deployment. It avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. The system includes a distinctive heart valve with a metal-free frame, delivered transfemorally via a flexible, 18 French delivery system for all sizes (23mm, 25mm, 27mm and 29mm). In the DISCOVER Trial, the mean transthoracic echo gradient at 30 days was 12.5mmHg and remained low at 12 months (12.3mmHg). All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory. The VARC Defined Device Success rate was 91%. At 30 days, 83% of patients had improved by more than one New York Heart Association (NYHA) functional class and this was maintained at 12 months, with 95% classified as NYHA Class I/II. The initial DISCOVER Trial was a prospective, multicenter 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. The trial has since expanded to additional sites and patients, enrolling patients in 23mm valve and 29mm valve trial arms. The 29mm valve received CE Mark in December 2013 and the 23mm valve is pending CE Mark approval.

Direct Flow Medical, Inc. Announces Investigational Device Exemption Approval for U.S. Pivotal Trial

Direct Flow Medical, Inc. has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate the pivotal phase of the SALUS Trial. The SALUS Trial is a prospective, non-randomized, multi-center, core lab adjudicated clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System at up to 30 sites. This technology is the first in class designed to treat aortic stenosis by replacing the patient's native aortic valve, while minimizing the degree and frequency of aortic regurgitation. The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural aortic regurgitation, 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 unlimited repositioning of the valve after full deployment. The system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients.

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