103 Devices for Transcatheter Surgery

Fast-Track proposals will be accepted.

Number of anticipated awards: [1-2 Phase I, 1 Phase II]

Budget (total costs):

  • Phase I: $400,000 for 12-18 months
  • Phase II: $3,000,000 for 24-36 months

 It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.

Summary

This solicitation will develop an ensemble of devices to enable a broad array of novel catheter treatments for structural heart disease in adults and children. These devices will deliver and secure sutures inside the beating heart without surgery and promise a dramatic impact on cardiovascular therapeutics.

Project Goals

The goals are to develop and test a collection of independent catheter devices for transcatheter electrosurgery procedures to treat adult and pediatric structural and congenital heart diseases without surgery. NHLBI has demonstrated the preclinical feasibility of such procedures including pledgeted suture annuloplasty, but commercially available tools are poorly suited for these applications in humans because of features including inadequate length, flexibility, radiopacity, and caliber. The devices are all variants of standard surgical tools specially adapted for application through flexible catheters under conventional imaging guidance including conspicuous sutures and pledgets, deflectable catheters for directing guidewires, knot pushers and lock devices to deliver and secure stitches under tension. Together this group of regulatory Class I or Class II tools would enable a wide range of novel but attainable non-surgical interventional cardiovascular procedures such as intracameral suture annuloplasty, valvular leaflet repair, and extraanatomic bypass.

Phase I Activities and Expected Deliverables

 A phase I award would develop and test working prototypes in swine. The contracting intramural laboratory wishes to test the final prototypes in vivo, and offers one no-cost testing round to the contractor if desired.

Below is a list of individual devices which are part of the suite, along with specific requirements. The devices must be able to function alone or together as components of the multifunctional suite.

1. Radiopaque sutures

  1. Must be visible in vivo under fluoroscopy and echocardiography
  2. MRI compatible although a small susceptibility artefact may be desirable to impart visibility.
  3. Exhibits mechanical and biological properties (tensile strength, strength retention, tissue reaction/thrombogenicity) similar to a commercial comparator known to perform satisfactorily (size O Ethibond EXCEL suture). Smaller caliber alternatives may be considered with appropriate justification.
  4. Preferred embodiments have different colors to each half, to simplify tying
  5. Minimal length 240cm
  6. Non-absorbable
  7. Hemocompatible

2. Guidewire to suture ‘connector’

  1. A low-profile device the can securely connect a 0.014” coronary guidewire to the radiopaque suture (item #1) with smooth transition, to allow the operator to pull one end of the guidewire in order to exchange for the suture through and across tissues through catheter devices. The connector “transition” must allow safe and reliable traversal of fibrotic annular structures.
  2. Must resist unlocking at high (>20N) forces
  3. Novel docking or crimping or connecting solutions are welcome
  4. May be integrated directly onto the suture.
  5. A preferred solution can pass through a 0.038”-compatible catheter lumen
  6. Hemocompatible

3. Catheter knot pusher

  1. A low-profile catheter device that can deliver a half-hitch or superior non-sliding suture along a transcatheter intracameral trajectory
  2. Length at least 110cm
  3. Must be able to pass through a fully deflected Abbott St Jude Agilis SML curl deflectable sheath 8.5Fr, and preferably would also pass curved coronary guiding catheters 8Fr to deliver a knot along two radiopaque sutures (item #1 above) and alongside one or more 0.014” guiding catheters
  4. Must be designed to allow tension to be maintained on the rail suture during delivery of each hitch
  5. A preferred embodiment would have a safety feature to enable the operator to loosen the knot.

4. Radiopaque felt or fabric pledgets

  1. Intended to allow sutures to apply focal tension to cardiovascular tissue without pull-through, including myocardium, annular tissue, and valvular leaflets
  2. Must be visible in vivo under fluoroscopy and echocardiography. The visibility maybe imparted focally using metal markers, or diffusely.
  3. MRI compatible although a small susceptibility artefact may be desirable to impart visibility.
  4. Must exhibit equivalent mechanical and biological properties to Ethicon Teflon Pledgets, ref PCP-20 e. Hemocompatible

5. Deflectable steering catheter

  1. Intended to guide at least one 0.014” guidewires traversing myocardial, annular, and leaflet tissue.
  2. A preferred embodiment has a mechanism to deliver precisely a second traversing guidewire a known distance (4-10mm, preferably adjustable) defined proximity to the first traversing guidewire.
  3. Preferred embodiments are deliverable through a 2.8mm inner diameter curved guiding sheath
  4. Preformed with at least two embodiments: one fixed curved such as a multipurpose-curve catheter, another curved with a 180-to-235-degree retroflex curve catheter, to allow apposition to both sides of valve annulus from transvenous, transarterial, transseptal, and transapical access routes. Preferred embodiments are deflectable up to 235-degrees/
  5. Must be conspicuous under fluoroscopy and under ultrasonography.
  6. Mechanical properties: resembling coronary guiding catheters or deflectable guiding sheaths to allow delivery of two commercial rigid 0.014” effector guidewires (with mechanical characteristics resembling Asahi Astato XS-20 guidewires).
  7. Hemocompatible

6. Adjustable transcatheter suture lock

  1. Allows secure and permanent locking of the pledgeted suture under tension
  2. Allows adjustment of tension, reversal or tension, and full retrieval after application
  3. The design prevents loss of suture tension during application
  4. Visible under X-ray and echocardiography
  5. MRI compatible although a small susceptibility artefact may be desirable to impart visibility.
  6. The lock delivery system need not be MRI compatible.
  7. Biocompatible and hemocompatible
  8. Must fit through 8.5Fr Agilis sml curl deflectable sheath during full deflection and alongside one or more O sutures and one or more 0.014” guidewires

7. Transcatheter Suture cutter

  1. Must cut suture through an 8.5Fr Agilis sml curl fully deflected, alongside one or more 0.014” guidewires
  2. Must have effector visible under X-ray and preferably also under ultrasound
  3. Must effectively cut the accompanying sutures in this suite

Phase II Activities and Expected Deliverables

In addition to meeting all requirements for Phase I, a phase II award would allow commercial introduction of the suite of tools together or independently as 510(k) devices substantially equivalent to marketed predicate devices. If this is not feasible, the phase II deliverable would be all testing and regulatory development for the device to be used in human investigation in the United States, under Investigational Device Exemption, along with devices sufficient to test in 30 human subjects.

The contracting DIR lab offers to perform an IDE clinical trial at no cost to the awardee. Complete IDE documentation and license and a suitable supply of clinical materials would constitute the deliverable.

For more information, see the FY2018 Contract Solicitation or contact OTAC.

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