Superior Treatment for Varicose Veins

The phlebectomy device was developed by a vascular surgeon for vascular surgeons.

Venous disease, including varicose veins and chronic venous insufficiency, is one of the most commonly reported chronic medical conditions and a substantial source of morbidity in the United States and the Western world. With average worldwide prevalence of 20%-25%, varicose veins constitute a major medical and economic challenge. Total annual costs for the treatment of chronic venous insufficiency are estimated at one billion dollars each for the U.K., France and Germany.

The main treatment modalities for superficial varicosities are Sclerotherapy and Ambulatory Phlebectomy which are performed with or without Saphenous vein stripping, ligation or ablation. Sclerotherapy, while considered less invasive by patients, this method suffers from a high recurrence rate, requires multiple visits, and may be complicated by postsclerotherapy pigmentation in up to 30% of cases, cutaneous necrosis, and rarely, anaphylaxis and deep vein thrombosis or pulmonary embolism. Stab Phlebectomy is an effective method with immediate results, however current practice requires numerous incisions to be made, resulting in a poor cosmetic outcome and a reluctance of patients to undergo this procedure. Transilluminated Powered Phlebectomy (TIPP) utilizes Smith & Nephew’s Trivex system for visualizing and resecting the varicosities. Although enabling a reduction in the number of incisions, this expensive technique does not shorten the operative time and is associated with a greater amount of postoperative complications such as bruising, and postoperative pain4. Despite the availability of treatment options, only about 5% of all symptomatic patients currently seek treatment, most probably due to fear of surgery. In addition, it is the company’s estimation that around 25% of patients who undergo sclerotherapy are unsuited for the treatment since their varicosities are larger than 4mm diameter.

The SIMEDEQ phlebectomy can be performed either as a stand alone phlebectomy procedure or as a phlebectomy complementary to a saphenectomy.

• Shortens procedure time from an average of 40 minutes to approximately 5 minutes!
• All veins are extracted through a 1-3 incisions – results in a superior aesthetics result
• Less tissue damage
• Reduced hematoma formation
• Reduced infection rates
• Less postoperative pain
• Shorter recovery time
• Extremely easy to use
• Operation may be performed by a single surgeon Effective for any vein larger than 4mm by diameter

Financial advantage - Shortens procedure time from an average of over 40 minutes to approximately 5 minutes.
Clinical advantage - Proven superior results and substantial post operative pain reduction.
Advanced stage of development - The device is going to be available as disposable.
Clinical proof - Successfully tested in more than 50 human operations and 2000 cadaver tests.
Accelerated market growth - Significantly enhances chances of referrals solely due to aesthetic reasons.
Strong intellectual property - A National Phase Patent, filled in USA, Canada, Europe, Japan, Australia, Russia, and Israel.
FDA track - 510K, Class-II device, no further clinical testing is required.
Efficiency - Operation may be performed by a single surgeon.
Market potential - Total relevant patient population – 69 million (Western world alone) and potential revenues of $500M.