Creating balloon catheters? Listen to this webinar and learn from Machine Solutions experts on key factors associated with creating, processing and testing precision balloon catheters.
Representing industry leading brands, BW-TEC, Crescent Design and MSI this 3-part Webinar provides you with insights related to Pleat & Fold, Balloon Forming and Testing balloon catheters.
Listen now to learn how you can repeatably produce and test balloons with confidence.
Pleat and Fold Process
Typically, the close diameter of the pleat head is not variable and is fixed to the full close of the head. That said there are applications where we can vary the close diameter to be slightly larger than nominal, this needs to be evaluated by engineering.
Our FFS systems can be configured with various types of luer or tube connectors so if the balloon is able to hold pressure & vacuum, we can process it.
Yes, pleat & fold heads of the same length can be exchanged between machine bases that have the same activation system (pneumatic or servo). There are also some models like the Workstation and FFS475/575 that can handle a limited range of pleat & fold head lengths.
Balloon Forming:
Balloon forming is oftentimes the most artful process related to Catheter Balloon Forming. Take a listen to learn about the critical ingredients associated with creating a repeatable balloon forming processes.
BW TEC’s Ruedi Altorfer steps through the key factors such as extrusion, repeatable necking, quality molds, process development and equipment selection.
A good guide (especially for PTCA and smaller PTA) 5 * Tube ID = Max Balloon OD is the way to go.
The Heating Blocks are completely disassembled, cleaned of lime and deposits and fitted with new heating cartridges, as well as insulation. After that, the Heating Blocks are tested and a test protocol is created. Thus, the Heating Blocks get back the same performance as new ones.
Yes, that is possible. The machine even offers the possibility to set a range in the process parameters, in which the operators can adjust the inputs to the extrusion characteristics.
Testing
Need confidence in your Catheter Balloon testing protocols? Listen and discover the various tests which can be used to ensure that your catheter balloons are safe, retain their quality, and perform successfully.
With over 25 years of hands-on experience, Christina King of Crescent Design shares her extensive knowledge on the topics of Burst, Leak, Fatigue and Compliance Testing.
Listen in as she covers specifics related to failure characteristics, parameter settings, proper measurement of pressurized balloons, and product characterization.
Contact our Catheter Testing team to schedule comprehensive testing services for catheters according to FDA guidance document recommendations and ISO standards. ISO 10555
The compliance setting is essentially the “gain” setting that tells the HBLT how much compliance the product and test fixturing has and allows for a smooth ramp. This is different from a compliance test where pressure versus diameter is tested directly.
The HBLT essentially just gives you a pass or fail based on the test criteria that has been specified. A dot matrix connected the HBLT will print more detailed information about the test. To get raw data from the test, Pressure Manager will need to be used to get what is essentially a CSV that contains pressure over time of the test.
.jpeg)
.png)
.png)
.png)
.png)
Advancing Medical Device Manufacturing through Synergistic Solutions for Exceptional Results.
2951 W. Shamrell Blvd. Suite 107
Flagstaff, AZ 86005 USA
