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Second 510(k) Premarket Notification for the Paragonix Sherpa Cardiac Transport System

Mon, 02/24/2014 - 6:14am
The Associated Press

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 System 1,2 (CTS).

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 Golding 3, 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.” Previous Announcements 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 Hospital (Boston).

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 of a Clinical Advisory Board for the Paragonix Sherpa™ Cardiac Transport System.

1 On February 6, 2013, FDA cleared for commercial distribution the first Sherpa Pak CTS 510(k) pre-market submission.
2 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 main campus.
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; 43(9):1553-1561.
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
8 Circulation 2010;121:e46-e215
9http://about.datamonitor.com/media/archives/314
10 Circulation 2011;123(8):933-944
11Circulation 2007;115(5)
12http://www.transplantliving.org
13http://optn.transplant.hrsa.gov
14http://www.uptodate.com/contents/heart-transplantation-beyond-the-basics

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