The Sherpa Pak⢠Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.
CAMBRIDGE, Mass.–(BUSINESS WIRE)– Paragonix Technologies, Inc. today announced that the European Society for Organ Transplantation (ESOT) accepted for presentation an abstract describing the performance of the Sherpa Pak⢠Cardiac Transport System during the upcoming 16th Congress of the European Society for Organ Transplantation to be held in Vienna, Austria from the 8th â 11th September 2013.
Lisa M. Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, âWe are excited to present the Sherpa Pak⢠Cardiac Transport System during the ESOT Congress. We look forward to future presentations in clinical forums discussing the exceptional organ transportation characteristics of the Paragonix Sherpaâ¢.”
Dr. Steven Tsui, MA, MD, FRCS,1 co-author on the abstract and the Director of the Transplant & Mechanical Circulatory Support program at Papworth Hospital, University of Cambridge, UK, commented, “The ESOT is a world-class forum where clinicians can meet and discuss challenges facing the organ transplantation community. The Sherpa Pak⢠Cardiac Transport System represents an innovative approach to heart storage and transportation. I look forward to a stimulating discussion with my colleagues during the Congress.” 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 November 6, 2012, filing 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. Currently, the availability of cardiac transplantation is governed by the âischemic timeâ, that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation (âISHLTâ) guidelines2 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours3,4, limiting the distance available to transport a donor heart. The Paragonix Sherpa⢠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 Sherpa⢠is designed to be used in conjunction with any of the currently available organ preservation solutions. Paragonix Sherpa⢠is fully disposable, eliminating problems associated with maintenance, device transport and contamination. The Sherpa Pak⢠Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart. Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure.5 With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year6, 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.7 The annual economic burden of treating heart failure exceeds $34.4 billion8, over 50% of which is due to the cost of hospitalization.9 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 $30,000.10 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 transplant.11 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 transplantation12, maximization of donor organ utilization has enormous potential in cardiac transplantation. The European Society for Organ Transplantation is a major scientific and not-for-profit society and dedicated to exchange knowledge about donation and transplantation, thus improving health and well-being of patients affected by end stage organ disease. Involving many dedicated voluntary professionals ESOT provides an extensive education program and generates best-practice guidelines in the field of transplantation. Based in Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix Sherpa⢠Cardiac Transport System, a novel, single-use organ preservation device to improve donor organ quality and extend donor organ preservation times. Paragonix Sherpa⢠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 South Texas Technology Management, a University of Texas collaborative technology transfer office. 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 States.
1 Dr. Tsui is a member of the Paragonix Clinical Advisory Board
2 ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010) 5 Datamonitor senior cardiovascular analyst Dr. Sergey Ishin. âCardiac 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.â http://about.datamonitor.com/media/archives/314