Bloomberg Anywhere Login

Bloomberg

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.

Company

Financial Products

Enterprise Products

Media

Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000

Communications

Industry Products

Media Services

Follow Us


August 05, 2015 8:54 AM ET

Healthcare Equipment and Supplies

Company Overview of Direct Flow Medical, Inc.

Company Overview

Direct Flow Medical, Inc. develops and manufactures transcatheter aortic valve systems for the treatment of aortic stenosis with minimal risk of aortic regurgitation. The company’s proprietary technology is also applicable to mitral and other heart valve anatomical sites. Direct Flow Medical was founded in 2004 and is based in Santa Rosa, California.

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 and President
Age: 61
Co-Founder, Chief Technology Officer and Director
Chief Financial Officer
Chief Operating Officer
Age: 47
Chief Commercial Officer
Compensation as of Fiscal Year 2015.

Direct Flow Medical, Inc. Key Developments

Direct Flow Medical Reports Two Year Data for its Transcatheter Aortic Heart Valve System

Direct Flow Medical, Inc. announced positive two year data from the DISCOVER CE Mark Trial studying its Direct Flow Medical® Transcatheter Aortic Valve System at the EuroPCR conference in Paris, France. Demonstrating excellent patient outcomes with few complications, the two year data were presented by Antonio Colombo, MD, PhD, from the Ospedale San Raffaele in Milan, Italy. The DISCOVER CE Mark Trial demonstrated an 80% survival rate at 24 months, continuing the positive trend showing 90% survival after one year and 99% after 30 days. All patients experienced mild or less post-procedural aortic regurgitation (AR), with 85% 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% of patients had improved by more than one New York Heart Association (NYHA) functional class, improving upon the 83% 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. 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. The DISCOVER CE Mark 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. The Direct Flow Medical system also avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. It includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23mm, 25mm, 27mm and 29mm). The Direct Flow Medical system received the CE Mark in January 2013. The system is currently available commercially in Europe and enrolling a pivotal IDE trial in the United States.

Direct Flow Medical, Inc. Announces Management Changes

Direct Flow Medical, Inc. has named Daniel Lemaitre as President and Chief Executive Officer (CEO), and David Boyle as Chief Financial Officer (CFO), effective immediately. The moves come as the company enjoys encouraging commercial uptake of its transcatheter aortic heart valve system in Europe, and continues enrollment in SALUS, its pivotal study in the United States. Current CEO Bernard Lyons will be retiring from the company. Lemaitre previously served as President and CEO of CoreValve from 2008 to 2009. David Boyle has served as CFO for five healthcare companies over the course of his 32-year financial career, most recently for Ogenx Therapeutics.

Direct Flow Medical, Inc. Appoints W. Randolph Chitwood, MD as Director of Surgeon Relations

Direct Flow Medical®, Inc. announced the appointment of Randolph Chitwood, MD, as Director of Surgeon Relations. Dr. Chitwood brings to the company more than 30 years of experience in cardiac surgery, with an expertise in complex valvular surgery, including aortic valve, mitral repair, cardiac rhythm and robotic heart procedures.

Similar Private Companies By Industry

Company Name Region
Amble Tech United States
AmniSure International LLC United States
The Firm of John Dickinson Schneider, Inc. United States
Sorenson Medical Products, Inc. United States
Vance Products, Inc. United States

Recent Private Companies Transactions

Type
Date
Target
Private Placement
September 12, 2014
--
 

Stock Quotes

Market data is delayed at least 15 minutes.

Company Lookup

Most Searched Private Companies

Company Name Geographic Region
Lawyers Committee for Civil Rights Under Law United States
NYC2012, Inc. United States
Bertelsmann AG Europe
Rush University United States
Citizens Budget Commission United States

Sponsored Financial Commentaries

Sponsored Links

Report Data Issue

To contact Direct Flow Medical, Inc., please visit www.directflowmedical.com. Company data is provided by Capital IQ. Please use this form to report any data issues.

Please enter your information in the following field(s):
Update Needed*

All data changes require verification from public sources. Please include the correct value or values and a source where we can verify.

Your requested update has been submitted

Our data partners will research the update request and update the information on this page if necessary. Research and follow-up could take several weeks. If you have questions, you can contact them at bwwebmaster@businessweek.com.