|[February 24, 2014]
Paragonix Technologies Inc., Announces Clearance of a Second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System
BRAINTREE, Mass. --(Business Wire)--
Paragonix Technologies, Inc. today announced that it has received
clearance for its second Premarket Notification (510(k)) with the US
Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac
Transport System1,2(CTS (News - Alert)).
The Sherpa Pak™ Cardiac Transport System is "intended to be used for the
static hypothermic preservation of hearts during transportation and
eventual transplantation into a recipient using cold storage solutions
indicated for use with the heart. The intended organ storage time for
the Sherpa Pak Cardiac Transport System is up to 4 hours".
As described in the product's labeling, following assembly, the Sherpa
Pak CTS™ is capable of maintaining cold storage solution temperature
between 4° and 8° C for up to 12 hours. The current cleared indication
further states that when using the device, "Donor hearts exceeding
clinically accepted static hypothermic preservation times should be
evaluated by the transplant surgeon to determine transplantability in
accordance with accepted clinical guidelines and in the best medical
interest of the intended recipient".
Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix
commented, "We are thrilled to have received clearance of a second
premarket notification from FDA for the Sherpa Pak™ CTS. Following
excellent market reaction to our first 510(k) cleared product, we
anticipate significant clinical interest for this innovative technology
in the markets where the Sherpa Pak™ CTS will be cleared for commercial
distribution. This is the second in a series of regulatory pre-market
clearances while we continue our development of several additional
Sherpa CTS products."
Leonard Golding3, MD, Chief Medical Officer at Paragonix,
commented, "Clearance of a second Pre-Marketing Notification (510(k))
with the US Food and Drug Administration (FDA) for our Paragonix Sherpa
Pak™ CTS, is an important step towards introducing this technology into
clinical practice. The Sherpa Pak™ CTS will enable standardization of
donor heart preservation and transportation."
Paragonix previously announced on January 27, 2014, presentation
discussing the Sherpa Perfusion™ Cardiac Transport System during the
2014 Cutting Edge of Transplantation Meeting.
Paragonix previously announced on December 18, 2013, closing of the
Company's convertible $1.1M debt financing.
Paragonix previously announced on December 17, 2013, filing of a 510(k)
Pre-market Notification Application with the US Food and Drug
Administration for the Paragonix Sherpa™ Pak Transporter.
Paragonix previously announced on November 18, 2013, filing of a second
510(k) Pre-Market Notification Application with the US Food and Drug
Administration for the Paragonix Sherpa™ Cardiac Transport System.
Paragonix previously announced on July 22, 2013, Publication by the
ASAIO (American Society for Artificial Internal Organs) Journal of
"Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure
of Donor Organ Viability"
Paragonix previously announced on June 10, 2013, Presentation of "An
Innovative, Novel Hypothermic Storage System For Donor Hearts,"
discussing the Sherpa Pak™ Cardiac Transport System during the 16th
Congress of the European Society for Organ Transplantation held in
Vienna, Austria, 8th - 11th September 2013
Paragonix previously announced on February 12, 2013, clearance of a
510(k) pre-marketing notification application with the US Food and Drug
Administration for the Paragonix Sherpa™ Cardiac Transport System
Paragonix previously announced on July 16, 2012, award of a Phase I
Small Business Innovation Research (SBIR) Grant to support the
pre-clinical development of the Paragonix Sherpa™ Cardiac Transport in
collaboration with the Transplant Center at Massachusetts General
Paragonix previously announced on June 25, 2012, Appointment of Leonard
A. R. Golding, MB, BS, FRACS, FRCS(C), FACC as Chief Medical Officer.
Paragonix previously announced on June 18, 2012, Formation (News - Alert) of a Clinical
Advisory Board for the Paragonix Sherpa™ Cardiac Transport System.
About the Paragonix Sherpa Pak™ Cardiac Transport System and the
Sherpa Perfusion™ Cardiac Transport System
The Sherpa Pak™ CTS is intended to provide a safe, consistent method for
cold ischemic storage and transport of donor hearts to recipients for
implantation. The Sherpa Pak™ CTS is intended for transport of hearts
within the time frame currently considered as routine medical practice.
Currently, however, the availability of cardiac transplantation is
governed by the "ischemic time", that being, the elapsed time from heart
donation to recipient implantation. According to The International
Society Of Heart and Lung Transplantation ("ISHLT") guidelines4
for the care of heart transplant recipients, the projected ischemic time
should not exceed 4 hours5,6, limiting the
distance available to transport a donor heart. The Sherpa Perfusion™
Cardiac Transport System under development combines innovative
oxygenated perfusion of organs and safe organ storage with the goal of
extending ischemic time to 12 hours, significantly altering the
transportation range of donor hearts. As with its predecessor the Sherpa
Cardiac Transport System, Sherpa Perfusion™ is designed to be used in
conjunction with any of the currently available organ preservation
solutions indicated for use with donor hearts and is fully disposable,
eliminating problems associated with maintenance, device transport and
About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold standard therapy for
patients in end-stage heart failure.7 With over 5.8 million
Americans currently diagnosed with heart failure (HF), growing at an
annual rate of 400,000 per year8, there is a persistent need
to provide end-stage heart failure support to this expanding population.
Estimates of the prevalence of symptomatic HF in the general European
population are similar to those in the United States.9 The
annual economic burden of treating heart failure exceeds $34.4
billion10, over 50% of which is due to the cost of
hospitalization.11 The financial demands associated with
transplantation are considerable. The estimated first year costs for
heart transplant are $997,700, and subsequent annual costs can easily
exceed $30,00012. In the United States, around 30,000 people
die annually from end-stage heart disease. As of June 1, 2012, 3,203
patients in the United States are on the waiting list for a heart
transplant13. Based on 2011 data, just over 2,300 patients
will receive a live-saving transplant each year, which is reflective of
the enormous donor heart shortage. These data, however, only seem to
represent the tip of the iceberg. Assuming that up to 50,000 people with
end-stage heart failure are candidates for transplantation14,
maximization of donor organ utilization has enormous potential in
About Paragonix Technologies, Inc.,
Based in Braintree, Massachusetts and founded in 2010, Paragonix
Technologies Inc., is a privately held medical device company innovating
the Paragonix Sherpa™ Cardiac Transport System. In addition to the
products cleared for market, the company is developing a novel,
single-use organ preservation device to improve donor organ quality and
extend donor organ preservation times; Sherpa Perfusion™ Cardiac
Transport System combines innovative oxygenated perfusion of organs and
safe organ storage with the goal of extending ischemic time to 12 hours,
significantly altering the transportation range of donor hearts.
Paragonix has exclusively licensed University of Texas Health Science
Center San Antonio intellectual property from the Office of Technology
Transfer and Commercialization. Paragonix has established a pipeline of
donor organ transport devices that address the current donor organ
shortage by maximizing donor organ utilization, improving donor organ
quality and extending donor organ transport throughout the entire United
1 On February 6, 2013, FDA cleared for commercial
distribution the first Sherpa Pak CTS 510(k) pre-market submission.
Patents issued and pending.
3 Leonard A. R. Golding, MB,
BS, FRACS, FRCS(C), FACC, is on Staff in the Department of Biomedical
Engineering at Cleveland Clinic and has a secondary appointment in the
Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic's
4 ISHLT Guidelines for the Care of Heart
Transplant Recipients, Task Force 1: Peri-operative Care of the Heart
Transplant Recipient (Aug. 4, 2010)
5 J Heart Lung
Transplant 2001; 20(2):212.
6 J Am Coll Cardiol 2004;
7 Datamonitor senior cardiovascular
analyst Dr. Sergey Ishin. "Cardiac transplantation continues to be the
gold standard for the treatment of end-stage heart failure. However, the
number of potential transplants far exceeds the number of donors." http://about.datamonitor.com/media/archives/314
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