Manufacturing Awards 2012: Innovation, Medical: Direct Flow Medical

Company: Direct Flow Medical Inc.

Address: 451 Aviation Blvd., Ste. 107A, Santa Rosa 95403

Phone: 707-576-0420

Products: Transcatheter aortic heart valve replacement systems


Employees:   80

SANTA ROSA -- Direct Flow Medical, Inc., (DFM) developer of a unique, second-generation transcatheter aortic heart valve system, is using break-through technology and minimally-invasive catheter based procedures to replace diseased and defective heart valves in about 30 minutes, achieving positive, lasting results without major side effects often associated with previous alternatives.

Founded in 2004 with headquarters at 451 Aviation Boulevard in the Airport Business Center, DFM currently has 80 employees and a second technology and manufacturing facility located in Lake Forest, California.

“Our focus is 100 percent on bringing innovative, catheter based, heart valve replacement products to market,” said Bernard E. Lyons, Ph.D, President and CEO of the company. “The unique technology we have developed is also applicable to mitral and other heart valve anatomical sites.”

[caption id="attachment_57761" align="alignleft" width="130" caption="Dr. Charles Davidson"][/caption]

The firm’s initial product is an investigational device, not currently available for sale. It is undergoing clinical trials in Europe -- scheduled for completion this year -- during which the DFM aortic valve has been successfully implanted in 70 patients outside the USA, including over 40 patients in 2012. 

Patient #1, who received the implant in October 2007, continues to do well over his nearly five-year history with the device, according to the company. Clinical feasibility trials in the U.S., involving 30 test subjects, will begin in 2013.

[caption id="attachment_57756" align="alignright" width="315" caption="Direct Flow Medical technician Kim Nguyen uses a laser fabric cutter and printer to create the replacement heart valve cuff and to print an identification number on each template."][/caption]

DFM recently announced the appointment of Dr. Charles Davidson as the company’s first chief medical officer. He will be the primary interface with the medical profession and will help select sites for domestic clinical trials.

Dr. Davidson is currently Professor of Medicine at Northwestern University’s Feinberg School of Medicine, the Director of the Cardiac Catheterization Laboratory and Clinical Chief of Cardiology at Northwestern Memorial Hospital in Chicago.  He will divide his time between his present post and new assignment with DFM.

“I am very impressed with the DFM device as it is designed to allow for precise and predictable placement within the heart. Additionally, it conforms to aortic valve anatomy, thereby virtually eliminating any paravalvular leaks, also known as aortic regurgitation,“ Dr. Davidson said.

[caption id="attachment_57757" align="alignright" width="284" caption="Direct Flow Medical Technician Siphear Som (left) and Supervisor Miguel Guzman cut and inspect components of the delivery catheter which are used to position the heart valve implant during the procedure."][/caption]

As the company name implies, the new DMF valve enables blood to flow directly through the valve, not around it. It is also unique in that it allows assessment of patient outcomes and repositioning before final device deployment.

Dr. Lyons said the new valve design has the potential to improve patient outcomes compared to first generation devices and better serve the needs of a growing patient demographic.

According to the U.S. Census Bureau, those age 65 and older number some 40 million today, a figure estimated to rise to more than 72 million in 10 years.  Aging is associated with a variety of medical conditions, including high-risk patients with aortic stenosis (AS), a condition that can be corrected with advanced, lower risk interventions.

[caption id="attachment_57759" align="alignright" width="315" caption="Direct Flow Medical supervisor Juanita Mendoza-Vazquez (left) and assembler Jenny Chao attach pericardial tissue to the inflatable support structure in the manufacture of replacement heart valve used to treat patients suffering from aortic stenosis."][/caption]

“Our objective is to dramatically improve survival and quality of life for AS patients.  Prior to the development of the transcatheter aortic valve replacement (or TAVR) system open-heart surgery was the only option. However, in patients with significant co-morbidities and AS requiring traditional surgical valve replacement, there is a high morbidity and mortality rate.  Further, after aortic valve surgery these patients frequently have prolonged rehabilitation that can require placement in long-term care facilities.  We are confident that we can do much better with a less invasive valve replacement procedure,” Dr. Lyons said, “while shortening recovery and saving lives.”

He added that, in the past, up to 20 percent of the population could not be surgically treated, either because they were too old, and/or suffered from too many co-morbidities – including coronary artery disease, kidney and liver disease, peripheral arterial disease and frailty -- in addition to their aortic stenosis.  “We believe we will be able to effectively treat a significant percentage of this group.”

[caption id="attachment_57760" align="alignleft" width="315" caption="Direct Flow Medical technician Catalina Mendoza prepares to use a laser welder to fuse components of a tiny metal check valve (in her hand and smaller than a tooth pick) used to control inflation and deflation of the heart valve."][/caption]

There are two critical issues that this new DFM device addresses which have been problematic in the past – the ability to precisely position the replacement valve during the implant procedure, and the ability to reduce aortic regurgitation (leaking around the valve).  Further, the inflatable design of the DFM valve allows for full retrieval if a different size valve is warranted.

With this design, other potential clinical improvements include the reduction of dependency on pacemakers, as well as the reduction of vascular trauma caused during access, deployment and valve replacement.

The DFM valve is inserted in a small, collapsed and rolled format using a delivery catheter. Two rings, designed to conform and seal the space above and below the native valve site, are then inflated with two cc’s of saline solution during the positioning phase. 

Once the device is fully expanded and properly positioned, a polymer compound is injected into the rings replacing the saline to create a permanent support structure that will not leak. The inflatable ring “cuff” gives the physician full operator control during the positioning and orientation process. Unlike prior transcatheter heart valve solutions, the DFM device can be retrieved and resized, if clinically required.

“DFM’s goal is to reduce procedural or device related complications.  There are many clinical benefits associated with this novel device and our hope is to be able to offer this product in the U.S. within four years, given regulatory approvals,” Dr. Lyons said.

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