”We want to create the perfect anastomosis by demonstrating excellent clinical results across Europe and
the World”
We will see the C-REX
device assessed in robust
clinical studies.
In 2025 we will build on the strong results and confidence from our surgical colleagues to carry out a multicentre clinical trial
across Europe. We hope to replicate our excellent results in this robust study under the leadership of Dr Roel Hompes.
Manish Chand, Chief Medical Officer
THE CHALLENGE
In current clinical practice
stapling and suturing
are most common techniques for colorectal anastomosis
Colorectal surgeries globally per year
3.3M
8.6%*
Of surgeries will be complicated by anastomotic leakage
An estimate of $9bn will be spent annually worldwide to treat
complications of leakage **
The increasing number of adverse events after surgeries with stapling
is causing widespread concern ***
* Results of the international audit by the European Society of Coloproctology (2017)
** Includes additional costs of 30 days after surgery only. Lee et al, Surgical Endoscopy (2019)
*** FDA's letter to the Health Care Providers, March 8, 2019
THE SOLUTION
Innovative
Anastomotic
ring
C-REX® family of devices help
create adaptive anastomosis
without stapling or compression
throughout colon and rectum
Unique
C-REX® catheter system
For validation of anastomosis by
objective integrity pressure test and
precise X-ray visualization
during and after surgery
For all types of surgery
C-REX® family of devices are designed for laparoscopic, robotic and open surgeries and all types of anastomoses
LapAid®
Regulatory & Quality
CE Marked products
-
Medical Device Directive – MDD
- New Medical Device Regulation MDR – plan to comply by 2025
-
Device Class IIa – short term surgically invasive device – NO implant
-
ISO 13485 Quality Management System
-
Manufacturing in Sweden
- Controlled processes with Quality Control of all final devices
-
Training program for surgeons
- Workshops including hands-on practice of C-REX devices on simulation models
