In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

An estimated 120,000 people in the U.S. are currently waiting for a life-saving organ transplant. Unfortunately, the demand for donated organs far outweighs their availability. Patients needing a lung transplant, for example, often wait months before an adequate lung or pair of lungs becomes available.

Even with approximately 58% of Americans willing to donate their organs at the end of their life, the pool of donor lungs acceptable for transplantation is limited, either due to compatibility issues between the donor and the recipient, or issues related to the condition of the lung.

A recently approved device manufactured by XVIVO Perfusion, Inc. has the potential to increase the pool of donor lungs by allowing the safe transplantation of previously unacceptable organs. The XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate is a machine that warms, flushes, preserves, and ventilates donated lungs for up to five (5) hours This allows the transplant team time to examine the lungs and evaluate their function. Perfusion, or the act of moving a liquid through the natural channels of an organ or tissue (in this case the donated lung or lungs), can allow for the safe transplantation of initially unacceptable organs because it:

  1. allows time for the lung(s) to re-establish their normal condition in an optimized environment,

  2. corrects physiologic problems caused by the buildup of fluid in the lung(s),

  3. dilutes and filters away any remaining donor blood and/or clots within the lung,

  4. supports re-expansion of collapsed portions of the lung(s), and

  5. allows time to assess and clean/suction residual and unwanted bronchial secretions.

The device consists of the XPS™ Perfusion Cart (both hardware and software), fluid path and non-fluid path disposables, and the STEEN Solution™, which is a clear, sterile, salt solution containing human serum albumin (HSA) and dextran 40. The system is designed to temporarily preserve and remove waste products from donor lung(s), helping maintain (and potentially improve) the condition of the donor lung tissue and giving the transplant team time to assess the lung(s) and whether they can be safely transplanted.

Interestingly, the XPS™ with STEEN Solution™ had previously secured FDA marketing authorization in 2014 via the humanitarian device exemption (HDE) regulatory pathway (H120003). The HDE is given to medical devices intended to benefit patients by treating or diagnosing diseases or conditions that affect less than 8,000 individuals in the United States per year. An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act, and is subject to certain profit and use restrictions. XVIVO Perfusion, Inc.’s current premarket approval (PMA) lifts the limit on annual patient use. This is an interesting and effective pathway for many devices that might be eligible for an HDE before they are ready to attack the full PMA process. Hopefully this device will continue to save lives as more lungs become available (and acceptable) for use!


Additional Reading:

  1. Device Approval Letter

  2. HDE Patient Information

  3. HDE Description

  4. Company Website

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