Authors: David Kelly MD, Nova Szoka MD
Ethicon Endo-Surgery, Inc. received FDA approval for the PROXISURE™ Suturing System on June 3, 2016.
The PROXISURE™ Suturing System consists of a reusable PROXISURE™ Suturing Device and a single use Suture Cartridge. It may be used in minimally invasive surgeries for placing interrupted or running stitches in soft tissue. The device fits through a 12mm trocar. It is 40cm long, with a 12mm diameter rotating (360 degrees) and articulating (45 degrees) distal end effector. The device uses a curved needle to pass suture through soft tissue. The curved needle passes 180 degrees via a mechanical process with each pull of the trigger, and is capable of suturing into flat or contoured surfaces. Suture Cartridges are available with Coated VICRYL™ or ETHIBOND™ sutures. The Suturing Device is reusable and must be cleaned and sterilized after each use.
No data from clinical studies was used in the FDA approval of this device.
The FDA has determined this device to be substantially equivalent to predicate devices. The predicate devices include mechanical devices where no energy passes through to the patient, are not battery operated, and do not use software.
Indications:
This device is indicated for suturing and knot tying in soft tissue during minimally invasive surgeries. It can be used to place interrupted or running stitches, and can suture into flat or contoured surfaces.
Contraindications:
- Contraindication to a minimally-invasive procedure.
- Contraindication to placement of a 12mm laparoscopic port.
Image courtesy: Ethicon
