Allium Group Receives CE Mark For Its Next-Generation Prostatic Stent

Main Category: Urology / Nephrology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 12 Jan 2009 - 8:00 PST

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Allium Group, the developer and manufacturer of innovative stents for the urinary, gastro-intestinal, pulmonary and peripheral vascular tracts, announced today that it has been awarded CE mark for its prostatic stent enabling commercialization of the system in the European Union and the countries that recognize the CE Mark.

"We are excited about receiving the European CE approval for our Prostatic stent. This achievement confirms the innovativeness and advantages of our stent technology and brings us closer to offering patients solutions that provide them with efficacious and immediate treatment, convenience, comfort and quality of life," said Limor Domnitz Gishri, CEO of Allium Medical. "Allium Medical has had a great deal of success in Europe with its biliary and ureteral stents that received CE marks and begun to market in 2007 and we believe that our prostatic stent will quickly become the "must have" solution for physicians and hospitals in Europe."

Allium's Prostatic Stents, used in patients with Benign Prostatic Hyperplasia (BPH) or with advanced Prostate cancer, have a triangular cross-section to match the contours of the prostatic urethral lumen and have the ability to exert varying degrees of radial force depending on the anatomy and function of this part of the male urethra. For example, higher radial force in its main body and lower radial force in the area near the external sphincter to prevent sphincteric dysfunction causing incontinence. These characteristics enable the Allium Prostatic Stents to conform to the prostatic urethral shape and function and offer a much improved comfort than existing stents in the long term.

"Today the leading treatment options for BPH demand continuous treatment pharmacological or surgical interventions which become expensive and uncomfortable. Such treatments may result in undesirable side effects such as erectile dysfunction (ED) retrograde ejaculation (dry orgasm), and, at times, bladder control problems," said Prof. Daniel Yachia, founder and CSO of Allium Medical. "We at Allium worked closely with physicians on the development of this stent and understood the need for a new minimally invasive, reversible and non-surgical office procedure that they can offer their patients."

Allium's 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.

"We are excited to be able to provide the medical community, physicians and patients, Allium's prostatic stent that will change the way BPH is treated in Europe," said Frank Menke, CEO of MenkeMed, the leading medical equipment distributor in Germany. "These stents are revolutionary in that they allow for a minimally invasive ambulatory procedure with immediate results. They are long-term temporary stents;l that can be inserted for up to 12 months and are easily removed making the procedure quick, efficient and cost-effective."

About Allium Medical

Allium Medical, Inc. is a medical device company offering next-generation stents based on a revolutionary 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. Founded in 2001, Allium Medical is a privately owned company led by Professor Daniel Yachia M.D., an urologist and acknowledged international authority on urinary system stenting. Allium was awarded CE marks for its biliary and ureteral stents, commenced sales in Europe in June 2007 and received follow-on orders from its distributors. Allium's prostatic stent received a CE Certification and will start distribution during the first months of 2009. Allium's headquarters, manufacturing and R&D facilities are located in Caesarea, Israel.

Allium Medical