Cardiogenesis Receives FDA Approval for PEARL 5.0 Robotic Hand Piece
November 13 2007 - 7:30AM
PR Newswire (US)
The First Minimally Invasive TMR Device Now Commercially Available
to Treat Severe Heart Disease IRVINE, Calif., Nov. 13
/PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC:CGCP.PK),
a leading developer of surgical products for transmyocardial
revascularization (TMR) today announced that the U.S. Food and Drug
Administration (FDA) has granted marketing approval for its PEARL
(Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery
System. The PEARL 5.0 is the only TMR delivery system compatible
with robotic surgical systems. "The Cardiogenesis TMR system uses
laser energy delivered through a small optical fiber to create
channels in heart muscle that doesn't have enough blood supply,
thus helping patients with disabling chest pain or angina," said
Louis A. Brunsting, III, M.D at Centennial Medical Center,
Nashville, TN, the principal investigator for the PEARL
investigational device exemption (IDE) clinical study. "The PEARL
5.0 device now allows this form of treatment to be performed
entirely endoscopically, with only a few port incisions. This new
minimally invasive approach, utilizing a surgical robotic system,
can markedly reduce hospitalization and recovery time for patients,
facilitating their return to an active lifestyle." The PEARL 5.0
Robotic delivery system consists of the CrystalFlex(TM) fiber optic
within a handpiece with an extended length flexible shaft to allow
it to be introduced through small incisions in the chest wall
through a 5 mm port. The end of the flexible shaft is designed to
enable the grasping and manipulation of the tip by surgical robotic
tools within the chest cavity for placement on the surface of the
targeted area of the heart muscle. The CrystalFlex fiber optic is
then advanced through the flexible shaft into the heart muscle
using the handpiece control to create a series of laser channels.
"FDA approval of the PEARL 5.0 is a significant achievement for
Cardiogenesis and an important advancement for patients suffering
from heart disease who are not candidates for coronary stents or
bypass surgery," said Richard Lanigan, President of Cardiogenesis.
"Physicians can now offer the proven clinical benefits of TMR
utilizing the less invasive approach via robotic surgical systems.
We believe the PEARL 5.0 Robotic delivery system approval increases
the number of patients who can be effectively treated with TMR."
About Transmyocardial Revascularization (TMR) TMR is for the
treatment of advanced coronary artery disease in patients whose
chronic angina symptoms are not relieved by medication and have an
area of the heart that cannot be treated by percutaneous
intervention or bypass surgery. Three out of four patients who
received TMR in studies have shown a significant reduction in their
angina pain. Additionally, patient benefits have been shown to
endure beyond five years, and TMR has been shown to help patients
live longer. TMR is reimbursed by Medicare, Medicaid and most
private payers when performed as a stand alone procedure and when
performed adjunctively to bypass surgery. About Cardiogenesis
Corporation Founded in 1989, Cardiogenesis (OTC:CGCP.PK) is a
leading medical device company that designs, develops and
distributes laser-based surgical products and disposable
fiber-optic accessories that treat diffuse coronary artery disease
with a procedure called transmyocardial revascularization (TMR).
Its products are marketed in the U.S. and around the world, and
have been shown to reduce angina and improve the quality of life in
patients. Cardiogenesis is located in Irvine, California. For more
information on the company and its products, please visit
http://www.cardiogenesis.com/ or the direct-to-patient website
http://www.heartofnewlife.com/ or call 800.238.2205. With the
exception of historical information, the statements set forth above
include forward-looking statements. Any forward-looking statements
in this news release related to the company's sales, profitability,
the adoption of its technology and products and FDA clearances are
based on current expectations and beliefs and are subject to
numerous risks and uncertainties, many of which are outside the
company's control that could cause actual results to differ
materially. Factors that could affect the accuracy of these
forward-looking statements include, but are not limited to: any
inability by the company to sustain profitable operations or obtain
additional financing on favorable terms if and when needed; any
failure to obtain required regulatory approvals; failure of the
medical community to expand its acceptance of TMR or PMC
procedures; possible adverse governmental rulings or regulations,
including any FDA regulations or rulings; the company's ability to
comply with international and domestic regulatory requirements;
possible adverse Medicare or other third-party reimbursement
policies or adverse changes in those policies; any inability by the
company to ship product on a timely basis; the company's ability to
manage its growth; adverse economic developments that could
adversely affect the market for our products or our ability to
raise needed financing; actions by our competitors; restrictions
contained in our convertible debt obligations requiring the
issuance of shares rather than repayment in cash; and the company's
ability to protect its intellectual property. Other factors that
could cause Cardiogenesis' actual results to differ materially are
discussed in the "Risk Factors" section of the company's Annual
Report on Form 10-KSB for the year ended December 31, 2006 and the
company's other recent SEC filings. The company disclaims any
obligation to update any forward-looking statements as a result of
developments occurring after the date of this press release.
DATASOURCE: Cardiogenesis Corporation CONTACT: William R. Abbott,
Senior Vice President and Chief Financial Officer, Cardiogenesis
Corporation, +1-949-420-1800 Web site:
http://www.cardiogenesis.com/ http://www.heartofnewlife.com/
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