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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


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cardiac catheters for delivery of cell suspensions

Cardiac Catheters for Delivery of Cell Suspensions

Donald Nick Jensen, DVM, MS

Division of Cardiovascular Devices

HHS/FDA/CDRH

focus of presentation
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

infusion of cells into coronary arteries
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

use of balloon catheters
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

ballon angioplasty catheters
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

considerations angioplasty catheters
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

needle tipped injection catheters
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

concerns needle injection catheters
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

concerns needle injection catheters12
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

concerns needle injection catheters13
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

additional discussion
Additional Discussion
  • Nick Jensen

Division of Cardiovascular Devices

(301) 443-8517, x171

DNJ@cdrh.fda.gov

  • Elias Mallis

Branch Chief, Division of Cardiovascular Devices

(301) 443-8517, x177

EYM@cdrh.fda.gov

FDA/CDRH/DCD