News | January 03, 2010

Trial Will Examine Stem Cell, Drug Delivery System

January 4, 2010 – The FDA's permission is sought to allow a safety and feasibility trial for the PHOENIX System, which allows tissue stimulation and injections of biologic or pharmacologic agents to the myocardium. The system is designed to treat patients with refractory angina.

Cardiogenesis Corp. today said it submitted an investigational device exemption (IDE) with the FDA. The PHOENIX System utilizes the thermoacoustic stimulated tissue zone created by a laser and introduces additional potent, therapeutic agents, including stem cells, into the myocardium to dramatically enhance the healing process.

The PHOENIX includes an integral CrystalFlex fiberoptic component consisting of 37, 100 µm diameter fibers, identical to the fiber optic component currently in use in the FDA approved Sologrip III and PEARL 5.0 hand pieces. The hand piece has been modified to include three 26-gauge needles positioned around the fiber optic fibers, which allow precise delivery of fluids, including stem cells, into the tissue surrounding the channels created by the fiber optic.

"To date I have successfully treated 18 patients utilizing the PHOENIX with bone marrow derived stem cells,” said Dr. Guillermo Reyes, department of cardiovascular surgery, Hospital Universitario La Princesa, Madrid, Spain. “These were patients with severe angina and not candidates for coronary bypass or percutaneous intervention. At follow up, all of the patients improved by at least two classes of angina, and one-half were angina free. Based on the published literature and my own experience, laser channeling has proven to be a valuable clinical option. This preliminary study suggests the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results and expand the utility of this approach."

These results build upon the in vivo research demonstrating that PHOENIX increased stem cell survival in targeted heart muscle when compared to direct injection alone.

For more information: www.cardiogenesis.com

Related Content

ProxiCor Extracellular Matrix Reduces Complications, Readmissions Following Pericardial Reconstruction
News | Stem Cell Therapies | April 19, 2019
Aziyo Biologics Inc. announced the publication of results from its landmark RECON study in the Journal of...
FDA Releases Final Guidances on Regenerative Medicine Therapies
News | Stem Cell Therapies | March 04, 2019
The U.S. Food and Drug Administration (FDA) recently finalized two guidance documents regarding regenerative medicine...
Heart Muscle Cells Created From Stem Cells Beat in Sync
News | Stem Cell Therapies | February 01, 2019
A team of Rutgers scientists have taken an important step toward the goal of making diseased hearts heal themselves – a...
FDA Clamps Down on Unapproved Stem Cell Therapies
News | Stem Cell Therapies | December 20, 2018
December 20, 2018 — The U.S.
Secant Introduces First Synthetic Regenerative Cardiovascular Graft for CABG
News | Stem Cell Therapies | January 17, 2018
Secant Group, in partnership with its sister company SanaVita Medical, announced new technology to advance...
News | Stem Cell Therapies | October 24, 2017
October 24, 2017 — Roche and Ncardia have reached a broad licensing agreement whereby Roche and its affiliate compani
BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System
News | Stem Cell Therapies | September 26, 2017
BioCardia Inc. recently announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the...
New Jersey Researcher Exploring New Stem Cell Therapies for Heart Attacks
News | Stem Cell Therapies | August 04, 2017
In petri dishes in her campus laboratory at New Jersey Institute of Technology, Alice Lee is developing colonies of...

An example of porcine cartdiac stem cells. Photo from the University of Miami Miller School of Medicine.

 

News | Stem Cell Therapies | June 12, 2017
June 12, 2017 — Heart muscle is one of the least renewable tissues in the body, which is one of the reasons that hear
Overlay Init