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Transcatheter Potts Shunt

Description:

  1. Transcatheter Potts Shunt

Fast-Track proposals will be accepted.

Number of anticipated awards: 2 Phase I, 1 Phase II

Budget (total costs, per award):  Phase I: up to $400,000 for up to 12 months; Phase II: up to $3,000,000 for up to 36 months

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Pulmonary hypertension of diverse etiologies causes severe symptoms and high mortality rate. Symptoms include inability to exercise, shortness of breath, right-sided congestive heart failure, and sudden death.  New pharmacologic options have significantly prolonged survival in adults with severe pulmonary hypertension.  These therapeutic options have led to nationwide centers of excellence for the care of pulmonary hypertension.  Despite successful pharmacotherapy, the disease progresses in the majority causing progressive right ventricular failure and declining functional status.  Heart-lung transplantation may not be an option.

Potts Shunt (between the left pulmonary artery and the descending thoracic aorta) is a surgical procedure that can divert blood flow to relieve right heart failure in patients with end-stage pulmonary hypertension {J Blanc, N Engl J Med, 2004;350:6, PMID 14762197 }.  It can be offered as a bridge to transplantation or as a destination therapy.  Surgical Potts shunt is morbid and complex.  A catheter-based Potts shunt has been described using commercial off-the-shelf devices, but shortcomings of these devices have caused fatal complications and limited adoption of the technique.

A simplified catheter system for Potts shunt would enable a new therapeutic option for severe or otherwise end-stage patients with severe pulmonary artery hypertension who are refractory to pharmacologic therapy. 

The commercial market is small enough to discourage the early development costs of a transcatheter Potts shunt.  There is a considerable unmet need for a purpose-built non-surgical aorto-pulmonary anastomosis system.

Project Goals

The goals of this project are to develop and test a transcatheter Potts Shunt prototype system in vivo in Phase I, and in Phase II to develop a clinical device and obtain an FDA Investigational Device Exemption for first human testing in the United States.

Phase I Activities and Expected Deliverables

The deliverable is a catheter system to establish a non-surgical Potts shunt (transcatheter pulmonary-to-aortic anastomosis) to treat refractory pulmonary artery hypertension.  

The system includes:

  1. Catheter system to allow traversal from donor to recipient blood vessel (typically left pulmonary artery and descending aorta).
  2. Catheter traversal system between donor and recipient blood vessel (most likely using transcatheter electrosurgery techniques)
  3. A system to establish donor and recipient side-to-side anastomoses, secure from extravasation, in a range of expected anatomies in adults requiring Potts shunt for severe pulmonary artery hypertension.  Proposed solutions should accommodate both adjacent and non-adjacent donor/recipient pairs.
  4. Delivery systems are ideally 12 French or smaller
  5. Solutions should be sufficiently resistive to allow patient-tailored shunt that balance decompressive flow against excessive shunt causing lower extremity hypoxemia
  6. Solutions should not cause hemodynamically significant obstruction in either donor or recipient vessel
  7. Solutions must resist inadvertent operator “pull-through” from both donor and recipient vessel
  8. Considerable detail should be supplied about the intended mechanical and biological performance of the anastomoses, including resistance to inadvertent separation and pull-through, hemorrhage, thrombosis, neointimal overgrowth, angulation, distortion or failure by patient and cardiovascular motion, and anticipated flow characteristics
  9. The implant and the delivery system should be conspicuous under the intended image-guidance modality; MRI compatibility is considered important
  10. Solutions must address mural recoil, kinking, and motion throughout the cardiac and respiratory cycles.
  11. Preferred solutions could also accommodate growing children by allowing late post-dilatation to adult vessel dimensions (ultimately dilatable to adult size vessels).

Phase I should focus on mechanical and biological performance of the proposed endograft, taking into account mechanical strength required for the application; geometry of the access vessels and geometry and morphology of target vessels; features to accommodate late post-dilatation achieve larger size in growing children, implantation, and visualization strategies.

At the conclusion of phase I, a candidate device design should be selected for clinical development based on in vivo performance of a mature prototype resembling a final design.  The contractor should provide a detailed report of pre-IDE interactions with the Food and Drug Administration to identify requirements for IDE development under Phase II, including the summary of mutual understanding.

The sponsoring NHLBI laboratory may offer to perform a limited number in vivo proof-of-principal experiments in swine (by mutual agreement) to confirm mechanical performance.

Phase II Activities and Expected Deliverables

The specific Phase II deliverables are as described under Phase I.  At the conclusion of phase II, the offeror should submit an investigational device exemption (IDE) for a USA first-in-human research protocol, involving at least 15 subjects.   If the exemption is not granted during Phase II, the offeror must provide an FDA response that indicates the specific deficiencies are limited to Current Good Manufacturing Design Verification and Validation, and that offeror proposed plan would be considered acceptable.  Furthermore, such a deficient application must be accompanied by a plan for Phase IIb funding and matching funding.

The sponsoring NHLBI laboratory may perform a limited number of in vivo proof-of-principal experiments in swine (by mutual agreement). 

NHLBI offers but does not require to perform the clinical trial at no expense to the offeror, to participate in the development of the clinical protocol, and to provide clinical research services.   The vendor is expected to perform or obtain safety-related in vivo experiments and data to support the IDE. 

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