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Allium Group, the developer and manufacturer of innovative stents for the urinary, gastro-intestinal, pulmonary and peripheral vascular tracts, announced that it has been awarded a CE mark for its large caliber, removable posterior urethral stent. This is a novel solution for patients who developed a stenosis at the bladder neck after radical removal of the prostate or the bladder for cancer.
"As the fourth stent to receive a CE Mark, Allium's technology is rapidly gaining an established presence throughout Europe as more hospitals and physicians discover the significant advantages of using removable stents as an effective solution," said Limor Domnitz Gishri, CEO of Allium Medical. "Allium is at the forefront of the expanding stent industry, developing the only next generation stents designed to fit site specific areas in the urinary and gastro-intestinal tracts. Allium's goal is to provide the global medical market with the tools to enhance patient treatment, comfort and quality of life with a minimally invasive approach."
The Allium Bladder-neck Stent is a removable device comprised of a super-elastic structure inserted into the posterior urethra of patients who have undergone radical prostatectomy (for prostate cancer) and radical cystoprostatectomy (for bladder cancer). In up to 18% of these patients a stenosis may develop at the anastomosis site, necessitating repeated dilatations to allow for a reasonable voiding. Currently, the conventional management of these stenoses is frequently performed mechanical dilations, endoscopic incisions or laser vaporization. The success rate of these procedures is low and patients have to undergo repeated treatments. The bladder-neck stent was developed based on the experience of Prof. Daniel Yachia, who successfully used removable stents in this difficult to treat area.
"We are glad that with the CE Mark, more European hospitals and physicians can offer their patients with Allium's new stents as a viable option that does not require a highly specialized reconstructive bladder neck repair procedure," commented Professor Daniel Yachia, founder and CSO of Allium Medical, an urologist and acknowledged international authority on urinary system stenting. "More urologists will also be able to perform this simple once a year treatment under regional anesthesia proven to be more effective than conventional treatments which have to be repeated frequently."
Allium's biliary and ureteral stents are currently being distributed through numerous partners in various European markets including Italy, United Kingdom, Germany and Austria, Benelux, Spain, Greece, Scandinavia and South Africa.
About Allium Medical
Founded in 2001, Allium Medical is a privately owned medical device company offering next-generation stents based on a proprietary technological platform that enables physicians to offer more effective stent solutions for enhancing patients' quality of life. Allium Medical has developed site-specific, anatomically and functionally compatible stents with applications in the urinary and gastro-intestinal tracts. Allium was awarded CE marks for its biliary and ureteral stents, commencing sales in Europe in June 2007 and receiving follow-up orders from its distributors thereafter. Distribution of Allium's new prostatic stent which also recently received a CE Certification, and the posterior urethral /bladder-neck stents will begin during the first months of 2009. Allium's headquarters, R&D and manufacturing facilities are located in Caesarea, Israel.
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