News | April 23, 2014

TransMedics Announce Final Results of PROCEED II Heart FDA Pivotal Trial at ISHLT

April 23, 2014 — The PROCEED II heart transplant U.S. Food and Drug Administration (FDA) pivotal trial results using the Organ Care System (OCS) Heart platform were announced at the International Society for Heart and Lung Transplantation (ISHLT) 34th annual meeting and scientific sessions in San Diego.

The OCS Heart PROCEED II FDA pivotal trial met its success criteria for both the primary effectiveness and safety endpoints by demonstrating the OCS is as safe and effective as the current standard of care (SOC) in preserving standard donor hearts for transplantation. These results were achieved despite the OCS arm having significantly longer total cross clamp time as compared to SOC. In addition, the data from PROCEED II demonstrated that circulating lactate levels of the OCS perfusion could be a useful parameter to evaluate donor hearts status ex vivo.

The trial data has been submitted to the FDA as part of a premarket notification and is currently under review by the agency.

"The successful completion of our OCS Heart PROCEED II trial and the filing of our FDA marketing application is an important milestone for TransMedics. This large international trial could be the defining work towards establishing ex vivo heart perfusion as a viable clinical option for donor heart preservation for transplantation to overcome the challenges of cold ischemic storage," said Waleed Hassanein, M.D., president and CEO of TransMedics Inc.

Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischemic storage (essentially placing organs on ice). Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs. The longer the organ is kept on ice, the greater the damage. Moreover, the cold storage technique does not enable any optimization or monitoring while the organ is being transported from donor to recipient. Partly because of the limitations of cold storage, it is estimated that globally, 70 to 80 percent of donor hearts cannot ultimately be used for transplantation.

TransMedics has developed a portable medical device capable of overcoming the limitations of cold storage for organ transplantation. The OCS technology was designed to provide a comprehensive solution to all three key limitations of the cold storage technique. The OCS minimizes cold ischemia injury by perfusing the organ with a blood-based perfusate; optimizes the condition of the organ by replenishing oxygen, nutrients and hormones that would otherwise become depleted; and provides continuous monitoring and assessment of the organ until the point of transplantation.

These unique capabilities of the OCS technology have the potential to improve patient survival, reduce post-transplant complications, increase utilization of current donor organs and improve cost effectiveness of the transplant procedure

For more information: www.transmedics.com

Related Content

CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Wearable monitors create patient generated health data, PGHD, that can help prevent acute care episodes in heart failure.

Wearable monitoring devices may offer a new tool to help prevent acute care episodes in heart failure.

Feature | Heart Failure| July 25, 2017 | Lola Koktysh
Despite their best efforts, many patients tend to develop heart failure after an acute event (e.g., a heart attack or
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Hospital Readmissions Analysis Across All Ages, Insurance Types Identifies High-Risk Groups
News | Business| July 20, 2017
July 20, 2017 — Clinician-researchers at Beth Israel Deaconess Medical Center (BIDMC) recently published a first-of-i
Sponsored Content | Videos | Cardiovascular Surgery| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Overlay Init