top of page
PRODUCT FOCUS: FREKA GASTROPEXY DEVICE (7601363)
Freka Gastropexy Device II
Attach gastric wall to abdominal wall with sutures
Gastropexy device II, only available from Fresenius Kabi in Australia & New Zealand*, allows attachment of the gastric wall to the abdominal wall with sutures and has been proven to lower PEG complications by up to 85% based on retrospective studies (4)(5).
Freka Gastropexy: Key features
Gastropexy allows attachment of the gastric wall to the abdominal wall using sutures and has been proven to reduce PEG complications by up to 85% based on retrospective studies (4)(5).
Combines the benefits of two procedures
The gastropexy technique combines the advantages of a conventional PEG placement with the benefits of a secure adaptation of gastric wall and abdominal wall, independent of PEG fixation.
Reduces complications significantly
Gastropexy lowers PEG complications by up to 85% based on retrospective studies (4)(5) safeguarding the stoma and preventing peritoneal gastric juice infiltration, thus reducing infection risks.
Enhanced stoma healing
Unlike traditional PEG, after gastropexy, the outer PEG plate can be loosely fixed against the abdominal wall (5). Thus, a better blood circulation around the stoma enhances stoma healing and early tube mobilisation minimises buried bumper syndrome (5,6,7).
Perfect your skills
To request a Fresenius Kabi Account Manager accompany one of our Freka Phantom devices along with a sample of the Freka Pexact and Gastropexy device II for you to try yourself, please use the "Contact Us" link at the top of this page.
Clinical excellence: Suitability for specific patients
A consecutive series (1) of 31 amyotrophic lateral sclerosis patients in whom endoscopic gastrostomy was considered too dangerous to perform underwent CT-guided percutaneous gastropexy and gastrostomy. All procedures were performed with a 15 FR Freka Pexact gastrostomy kit.
The procedure was performed successfully in 30 of 31 patients with a median age of 60 years.
No serious adverse events such as peritonitis, persistent local bleeding, systemic blood loss, or any local infection requiring surgical intervention were observed. Follow-up resulted in 7,473 cumulative gastrostomy days from the date of first placement.
The results suggest that the gastropexy technique is feasible and secure and may especially be advantageous in cases where endoscopic gastrostomy and sedation are contraindicated.
Patients with head and neck cancers may require nutritional support during and after treatment of their cancers and this is commonly done via a gastrostomy. Endoscopic gastrostomy placement is usually performed using a pull-through technique. However, pulling the PEG bumper past the tumour may risk seeding malignancy to the PEG site. In these cases a direct puncture technique may be preferred.
319 Freka Pexact insertions (2) were identified in 317 patients with an average age of 58 years. 99% (n=316) patients had a head and neck cancer as the indication.
Insertion via direct puncture was successful in 99% (n=316) and unsuccessful in 3 (0.9%) of patients.
It was concluded that Freka Pexact is a secure and reliable method of gastrostomy tube placement and overall, the complication rate had fallen using the Freka Pexact and the gastropexy technique.
In another study, 89 patient procedure (3) were performed under conscious sedation.
Freka Pexact PEG placement was achieved in all cases. Minor haemorrhage from the puncture site in one patient was the only immediate operative complication. Complete tube displacement during the first 30 days occurred in 7 patients (7.9%). Five of these had a new gastrostomy tube placed at the bed-side without difficulty. No significant PEG-site infections were recorded. The overall 30 day complication rate was 12.3%.
Serious complications were rare, but tube displacement remains a significant problem. Minor complication rates were comparable to the standard pull through technique, although PEG site infection appeared less often.In conclusion, Freka Pexact using the gastropexy technique provided a reliable direct puncture method for PEG placement.
Two different techniques for percutaneous endoscopic gastrostomy (PEG) have been developed: classical pull-through and direct puncture techniques.
Another study (4) compared the complication rate for both techniques in a large retrospective patient cohort.
Clinical data from patients who received a PEG in four high-volume centers for endoscopy were included retrospectively between January 2016 and December 2018. Patient characteristics and complication
rates were correlated in univariate and multivariate analyses.
Data from 1014 patients undergoing a PEG insertion by the pull-through technique were compared to 183 patients for whom the direct puncture technique using the gastropexy device available from Fresenius Kabi was used. The direct puncture technique was associated with a 50% reduction in minor and 85.7% reduction in major complications when compared to the pull-through technique.
Multivariate analysis of these data revealed an odds ratio of 0.067 (0.02–0.226; P < 0.001) for major complications in the direct puncture group.
It was concluded that compared to the pull-through technique, the direct puncture technique resulted in a significant reduction in complications and that the results suggest that the direct puncture technique may be preferable to improve patient safety.
Fresenius Kabi Gastropexy Device II design vs metal T-Anchor systems
A study (8) reviewed the direct puncture technique using a metal T-Anchor gastropexy system and reached the following conclusion:
“Performing a gastropexy with Cook’s T-anchors does not guarantee a successful gastropexy.”
In a total of 71 procedures with subsequent CT follow up, a total of 153 T-anchors were used and observed:
Short-term: 59.5% of the metal T-anchors were found intraluminally or within the stomach wall and 35.5% were found within the anterior abdominal wall musculature or subcutaneously.
Long-term (> 3 months): 25.0% of the metal T-anchors were found intraluminally or within the stomach wall and 26.4% were found within the anterior abdominal wall musculature or subcutaneously.
These limitations are virtually excluded when using the Gastropexy Device II:
-
The threads used with the Gastropexy Device II are not self-dissolving and can remain in the patient until the HCP decides to remove them.
-
Gastropexy is the attachment of the stomach lining to the abdominal wall. The ingrowth of metal is not a desired outcome, or patient friendly, and cannot be prevented when using a metal T-Anchor gastropexy system.
Figure 1.
Figure 2.
Fig. 1. A photograph of a deployed t-fastener (left) and a t-fastener needle containing an undeployed t-fastener.
Fig. 2. Computer tomography images demonstrating the four t-fastener location categories. The white arrows denote the t-fastener of interest: (A) intraluminal, (B) gastric wall, (C) abdominal musculature, and (D) subcutaneous.
Use of the device: Instructional video
Product details
To view the specifications of the Freka Gastropexy Device II click here.
Note: samples are only available to registered healthcare professionals.
If you would like to request a sample of the Freka Gastropexy device II or discuss the product in more detail with your local Fresenius Kabi Account Manager please complete the form below and we'll be in touch.
Request a sample or discussion with your local Account Manager
References
1. Maximilian de Bucourt, Federico Collettini, Christian E Althoff, Florian Streitparth, Johannes Greupner, Bernd Hamm and UK Teichgraber. CT fluoroscopy-guided percutaneous gastrostomy with loop gastropexy and peel-away sheath trocar technique in 31 amyotrophic lateral sclerosis patients. Acta Radiologica 2012; 53: 285–291. DOI: 10.1258/ar.2011.110662.
2. Suhail Ahmed, Katherine Bowering, Naveen Polavarapu, Roger Nicholson, Paul Thomas, Richard Sturgess. Pexact: Analysis of 319 Procedures Performed at the Digestive Diseases Unit, University Hospital Aintree. Gastroenterology, Volume 138, Issue 5, Supplement 1S-1-S-906, 2010 DDW Abstract Supplement.
3. H. Gupta, R. Manikandan, A. Byrne, R. Nicholson, P.A. O’Toole. Pexact Direct-Puncture PEG Placement: Our First 12 Months Experience. Volume 65, No. 5 : 2007 Gastrointestinal Endoscopy AB279.
4. Leonie Schuhmacher, Christian Bojarski, Victoria Reich, Andreas Adler, Winfried Veltzke-Schlieker, Christian Jürgensen, Bertran Wiedenmann, Britta Siegmund, Federika Branchi, Julianne Buchkremer, Steffen Hornoff, Dirk Hartmann, Christoph Treese. Complication rates of direct puncture and pull-through techniques for percutaneous endoscopic gastrostomy: Results from a large multicenter cohort. Endosc Int Open 2022; 10: E1454–E1461.
5. Kishta J., Reich V., Bojarski C. Hybrid-PEG – Experiences after more than 300 hybrid PEGs at the Charité. Endo-Praxis 2021; 37: 95–99.
6. Cyrany J., Rejchrt S., Kapacova M., Bures J. Buried bumper syndrome: A complication of percutaneous endoscopic gastrostomy. World Journal of Gastroenterology. 2016 Jan 14;22(2): 618-627.
7. Devia J, Santivañez JJ, Rodríguez M, Rojas S, Cadena M, Vergara A. Early Recognition and Diagnosis of Buried Bumper Syndrome: A Report of Three Cases. Surg J (N Y). 2019 Aug 22;5(3):e76-e81. doi: 10.1055/s-0039-1692148. PMID: 31448333; PMCID: PMC6706275.
8. Sydnor RH, Schriber SM, , Kim CY. T-Fastener Migration after Percutaneous Gastropexy for Transgastric Enteral Tube Insertion. Gut and Liver 2014;8:495-499. https://doi.org/10.5009/gnl13204.
*Fresenius Kabi Data on file for configuration
For all Freka products always read the label and follow the instructions for use.
bottom of page