Allium Medical Solutions Ltd., which specializes in minimally invasive technologies providing to large markets innovative solutions for clinical needs that are not adequately addressed, announced today that its urological stents received CE Mark for a new indication for treating urethral fistula after a successful trial.
An ureteral fistula is caused by injury during surgery or through trauma leading to the leakage of urine to the abdominal cavity. Currently this condition is treated by surgery (suturing the tear), or by implanting a plastic implant which yields low efficacy. Both of those methods result in the growth of ill-defined scar tissue which increases the chances of strictures after the healing process is completed.
Thanks to the Allium stents’ unique structure (nitinol alloy covered with a bio-compatible polymer) which helps the body grow a scar tissue layer in the inner circumference of the ureter while maintaining its diameter), success rates of treating ureteral fistula with the stents are very high. The CE Mark was approved based on a retrospective multicenter study that was carried out in medical centers in Germany (the Charité Universitätsmedizin Berlin medical center – one of the largest hospitals in Europe and among the most prominent medical centers in Europe and globally) – and in Italy (in the Rome INI clinic). As part of the study, the Company’s stents were implanted in 47 patients and the success rate was 92%.
In the opinion of the Company, receiving the CE Mark for the new indication constitutes a significant stage in proving the stents’ efficacy as an implant triggering cell generation and healing of damaged areas in the ureter and the urethra.
Ariel Rubashkin, CEO of Allium Medical Solutions: “We continue selling our existing product lines and working to expand the Company’s target markets. The CE Mark was received after a successful clinical trial which proves again the value of Allium Medical’s unique stents technology. Allium will act to leverage its geographic distribution and international network of distributors and sell its urological stents to treat this new indication as early as the current quarter”.
You can have a look at the complete press release here.
In Cardiolink, as the Spanish distributor of Allium Medical’s products, we would like to encourage you to have a look at the Allium stents main features, available here.