Catheters

Sample Case Studies

RF Soft-Tissue Ablation Catheter

Client: Spin-off from large medical device company with existing design

Device: Bi-Polar F catheter for soft-tissue ablation

Hantel Contributions: Received existing documentation into Hantel doc Control, Material selection, Materials procurement, Process development, Assembly fixture design and fabrication, Design documentation, Verification Test development, Verification of the design, GMP manufacturing.

Results: Project kick-off to Clinical-Ready units in 6 months.

 

Transeptal Needle/Dilator Catheter Set

Client: Pre-IPO Medical Device Start-up with breakthrough technology

Device: Needle/Dilator system for trans-septal approach to the left atrium

Hantel Contributions: Benchmarking against existing systems, materials selection, brainstorming, prototyping, design development, test method development to simulate the septal wall, design documentation, sterilization method selection, verification testing, biocompatibility test management, manufacturing process development, GMP manufacturing.

Result: Concept to clinically used device in 12 months. Ongoing manufacturing for clinical trials.

 

RF Catheter for Cardiac Applications

Client: European, VC-backed Start-up

Device: Steerable catheter with more than 25 elements along its length

Hantel Contributions: Prototyping, Material Selection, Design controls, Technology development, Manufacturing process development

Result: Initial prototypes 5 months from project start date.