cardiac catheters for delivery of cell suspensions
Download
Skip this Video
Download Presentation
Cardiac Catheters for Delivery of Cell Suspensions

Loading in 2 Seconds...

play fullscreen
1 / 14

Cardiac Catheters for Delivery of Cell Suspensions - PowerPoint PPT Presentation


  • 227 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Cardiac Catheters for Delivery of Cell Suspensions' - johana


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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

[email protected]

  • Elias Mallis

Branch Chief, Division of Cardiovascular Devices

(301) 443-8517, x177

[email protected]

FDA/CDRH/DCD

ad