Cardiac catheters for delivery of cell suspensions
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Cardiac Catheters for Delivery of Cell Suspensions. Donald Nick Jensen, DVM, MS Division of Cardiovascular Devices HHS/FDA/CDRH. Focus of Presentation. Potential questions related to the interaction between cell suspension and catheter

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Cardiac Catheters for Delivery of Cell Suspensions

Donald Nick Jensen, DVM, MS

Division of Cardiovascular Devices

HHS/FDA/CDRH


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Focus of Presentation

  • Potential questions related to the interaction between cell suspension and catheter

    • Standard questions for consideration - suggested to all sponsors of IND’s / cell delivery cardiac catheters

  • Example cell delivery methods / devices

    • Infusion of cells into coronary artery during balloon occlusion of artery

    • Percutaneous, intracardiac, needle-tipped injection catheter for transendocardial injection into myocardium

    • No cardiac catheters for cell delivery approved in U.S.

FDA/CDRH/DCD


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Infusion of Cells into Coronary Arteries

  • Advantages - simplicity, ease of use

  • Not suitable for all cell suspensions?

    • Requires migration of cells from vasculature into myocardium?

    • Potential for embolization / microembolization?

  • Demonstrated during case series

    • Acute MI (hours-to-days), commonly following emergency PCI / stenting

    • Chronic MI / ischemia

FDA/CDRH/DCD


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Use of Balloon Catheters

  • Balloon catheter occludes artery proximal to treatment region

  • Cells infused via balloon catheter lumen or via infusion catheter lateral to balloon

  • Allows infusion at > arterial pressure

    • Increase dispersion within vasculature?

    • Increase adhesion of cells to endothelium?

    • Increase migration of cells into myocardium?

FDA/CDRH/DCD


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Ballon Angioplasty Catheters

  • Designed to “stretch” occluded arteries and/or stents to desired diameters

    • Can use balloon for occlusion. If guidewire lumen can potentially use for infusion of cell suspension.

  • Considerations if angioplasty catheters are used for infusion of cell therapies

    • Potential for catheter materials to adversely affect viability / functionality of cells? Also - guidewire lumens commonly coated with lubricants.

FDA/CDRH/DCD



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Considerations - Angioplasty Catheters

  • Balloon designed to stretch artery must instead occlude artery without damaging artery wall

    • Arterial stretch during angioplasty induces stenosis

    • Essential to develop / demonstrate safe methods for balloon inflation during delivery of cell therapies

    • Balloon pressure-diameter relationship (compliance) varies widely among angioplasty catheter designs

    • Methods for one catheter may not work for others

  • Concentrated cell suspensions may clog lumen?

  • Balloon catheter guidewire lumens / connectors not tested to sustain high pressures?

FDA/CDRH/DCD


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Needle-Tipped Injection Catheters

  • Advantages

    • Direct injection into desired myocardial locations

    • Potentially usable with all cell types

  • Cardiac catheter or system (catheter plus sheaths) with retractable, distal injection needle

    • None approved for sale in U.S.

    • Some design requirements potentially similar to cardiac ablation catheters, endocardial biopsy caths

      • Tip must be steerable / deflectable to various locations

      • Sufficiently stiff to maintain tip contact with cardiac wall

FDA/CDRH/DCD


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Concerns - Needle Injection Catheters

  • Clogging of lumen by cell suspension?

    • Small injection volume, concentrated cell suspension

    • Small injection needle / lumen diameter

    • 20+ injections per treatment session

  • Is cell viability / functionality adversely affected by lumen materials or by shear force?

  • Inadvertent injection into LV cavity? (systemic)

    • May be difficult / impossible to ensure continuous contact between catheter tip and endocardium?

    • Kalman JM, et al. American Heart J 1997;133:8-18.

FDA/CDRH/DCD


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Concerns - Needle Injection Catheters

  • Control / limit - maximum needle extension?

    • Avoid injection / laceration of surrounding organs

    • Safety if cell suspension is delivered pericardial / thoracic / systemic (via lymphatics)?

    • Curves in catheter may alter needle extension

    • Possibly difficult to avoid occasional injection into pericardial space if heart has minimal epicardial fat?

      • Locally “thin” regions of the LV wall

      • Compression / stretch of LV wall by catheter tip

      • Force of injection may separate myocardial and epicardial cells?

FDA/CDRH/DCD


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Concerns - Needle Injection Catheters

  • Are depth and “spread” of injection critical aspects of therapy?

    • Does injection of cells near “more ischemic” endocardial region = injection near less ischemic epicardium?

    • Is a minimally dispersed bolus of cells at each injection site = wider dispersion of cells at each injection site?

    • Catheter design, cell suspension characteristics, injection speed - all may affect depth and spread?

      • Will different injection catheters deliver the same therapy?

      • Animal studies can characterize depth and spread

    • Is it important to characterize “therapy delivered” ?

FDA/CDRH/DCD


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Additional Discussion

  • Nick Jensen

    Division of Cardiovascular Devices

    (301) 443-8517, x171

    [email protected]

  • Elias Mallis

    Branch Chief, Division of Cardiovascular Devices

    (301) 443-8517, x177

    [email protected]

FDA/CDRH/DCD


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