Epidemiology: Prevalence

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2 Epidemiology: Prevalence More than 30 million Americans suffer from varicose veins or a more serious form of venous disease called Chronic Venous Insufficiency (CVI). 1 Of the over 30 million Americans affected: Only 1.9 million seek treatment annually 1,2 While the vast majority remain undiagnosed and untreated CVI Prevalence *,1,2 30,000,000+ Seek Treatment *2 1,900,000 Treated 447,0002 (Table 30) *Statistics based on individuals over the age of Gloviczki P, et al. The care of patients with varicose veins and associated chronic diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. JVS; May Lee, A. US markets for varicose vein treatment devices Millennium Research Group, Inc. (A Decision Resource, Inc. Company), May 2011.

3 Prevalence and Etiology of Venous Insufficiency Venous reflux disease is 2x more prevalent than coronary heart disease (CHD) and 5x more prevalent than peripheral arterial disease (PAD) 1 Venous Reflux Disease Coronary Heart Disease Peripheral Arterial Disease Congestive Heart Failure Stroke Cardiac Arrhythmias Heart Valve Disease Brand FN, Dannenberg AL, Abbott RD, Kannel WB. The epidemiology of varicose veins: the Framingham Study. Am J Prev Med 1988; 4(2):96-101

4 Possible Risk Factors and Symptoms of Venous Insufficiency Possible risk factors for venous insufficiency: Gender Age Heredity Pregnancy Standing occupation Obesity Prior injury or surgery Obstruction Symptoms of venous insufficiency: Leg pain, aching, or cramping Burning or itching of the skin Leg or ankle swelling Heavy feeling in legs Skin discoloration or texture changes Open wounds or sores Restless legs Varicose Veins

5 Etiology & Pathophysiology: CEAP C 0 : Asymptomatic. No visible or palpable signs of venous disease C 1 : Spider veins, reticular veins, telangiectasias C 6 : Open Skin Ulcers C 5 : Healed Skin Ulcers C 4 : Pigmentation, Lipodermatosclerosis C 3 : Edema C 2 : Varicose Veins Increased Pain and Reduced Quality of Life Photos courtesy of Rajabrata Sarkar, MD PhD

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9 Venous return to right side of heart accomplished thru the actions of the calf muscle pump and venous valves.

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12 Patient Assessment & Diagnosis Patient Assessment Ultrasound Diagnostic Study

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17 Most commonly used for tributaries and reticular veins. Sodium tetradecyl sulfate, polidocanol, and hypertonic saline most commonly used agents Endothelial damage the result of either osmotic action or protein denaturation

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19 Percentage of patients treated with the 1.0% polidocanol solution experienced the following mild to moderate adverse events: Closure Rate Reported pain Experienced retained coagulum (blood trapped in varicosities) 15.5% 27.6% 86.20% Experienced a DVT 8.6% Duration 8 Weeks CFVTE 6.9% Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17

20 Duplex ultrasound response at 8 weeks: Placebo PEM 0.125% PEM 0.5% PEM 1.0% Duplex responders 1.8% 59.6% 83.3% % 2 The most commonly reported adverse events in %: Placebo PEM 0.125% PEM 0.5% PEM 1.0% Pain in extremity 10.5% 12.3% 5.0% 15.5% Retained coagulum % 11.7% 27.6% Thrombophlebitis superficial 1.8% 7.0% 13.3% 3.4% Deep vein thrombosis % CFVTE % 3.3% 6.9% Tenderness % 6.9% 1 P < P < compared to PEM 0.125% 3 CFVTE Common Femoral Vein Thrombus Extension. This is non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein (similar to EHIT). Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17

21 Belcaro, G, Nicolaides, AN, Ricci, A, et al. Endovascular sclerotherapy, surgery, and surgery plus sclerotherapy in superficial venous incompetence: a randomized, 10-year follow-up trial--final results. Angiology 2000; 51:529.

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23 Tumescent needle Injection sites

24 The Venefit Procedure Using the ClosureFast Catheter Minimally invasive treatment option for patients with varicose veins and CVI Controlled and consistent radiofrequency (RF) energy to the ClosureFast catheter The catheter heats the vein wall and contracts the vein wall collagen, thereby occluding the vein

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26 Proebstle Study 1,2 Multi-center 326 patients 99.6% occlusion at 6 months 90.0% occlusion at 5 years vs VANISH 2 Study 3 Multi-center 232 patients 87.9% occlusion at 8 weeks No data at 5 years 1 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17 *ClosureFast long-term data is shown for perspective only and not meant to imply that the data can be used in a head-to-head comparison with the data from the Vanish 2 study.

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28 ClariVein TM *

29 Closure Rate 96.70% Duration 260 days Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72

30 Proebstle Study 1,2 Multi-center 396 limbs (326 patients) 99.6% occlusion at 6 months 90.0% occlusion at 5 years vs Elias Study 3 Single-center 30 limbs (29 patients) 96.7% occlusion at 260 days No data at 5 years 1 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72 *ClosureFast long-term data is shown for perspective only and not meant to imply that the data can be used in a head-to-head comparison with the data from the Elias study.

31 Percent Occlusion 102.0% 100.0% 98.0% 96.0% 94.0% 92.0% 90.0% 88.0% 86.0% 84.0% 99.7% 87.9% 2-8 Weeks 98.6% 96.7% 3-6 Months 95.2% 94.2% 83.7% 90.0% 1 Year 5 Years Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17 CLF EVLA MOCA UGFS

32 But is there an even better option to treat cvi?

33 Venaseal Procedure: Non-tumescent, nonthermal, Nonsclerosant

34 FDA Cleared Cyanoacrylate Adhesives (not mutagenic, pyrogenic, hemolytic, sensitizing, irritating or cytotoxic) 2 Adhesive Date Use Cyanoacrylate (CA) Adhesives 1950s Wound adhesives Histoacryl Blue * 1980s Skin incisions Dermabond * 1998 Skin incisions/lacerations Ethicon OMNEX * 1998 Surgical adhesive Trufill * 2000 Liquid embolic system (AVM applications) Indermil * 2002 Skin incisions/lacerations 1 Pollak J, White R. The use of cyanoacrylate adhesives in peripheral embolization. J Vasc Interv Radiol 2001; 12: p Lawson J. et.al. Sapheon: the solution? Phlebology 2013;28Suppl1:2-9 Review article page 3 *Trademark of its respective owner.

35 Widely used medical tissue adhesive. 1 Antimicrobial effect against grampositive organisms. 2 Used safely on millions of patients with no reported carcinogenicity in humans (1986 study). 2 1 Lawson et al. Sapheon: the solution? Phlebology 2013, 28 Suppl 1:2-9, p3 2 Quinn J., Tissue Adhesives in Clinical Medicine, 2nd ed.(2005) p 34-35

36 Properties of Ideal Cyanoacrylate for Venous Closure Ideal viscosity Polymerize quickly Soft and elastic Maintains a strong bond Eliminate need for compression stockings* *Some patients may benefit from compression stockings post procedure.

37 When cyanoacrylate (CA) comes in contact with blood or plasma, it begins to polymerize. The body encapsulates the polymer as a foreign body. CA triggers inflammatory reaction in the vessel wall resulting in occlusion. Almeida J. et.al. Cyanoacrylate adhesive for the closure of truncal veins: 60 day swine model results. Vasc and Endovasc Surg (2011) 000(00) 1-5. DOI / p.1

38 Features of the VenaSeal Procedure Procedure Features Eliminates need for tumescent anesthesia. No risk of thermal injury. No post treatment compression stockings needed. 1,2 * Rapid return to normal activities. 2 1 Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, *Some patients may benefit from compression stockings post procedure.

39 Feasibility Study 1 escope 2 (European multicenter study) VeClose 3 (U.S. pivotal trial) 38 Patients, enrollment completed Aug , 3, 6, 12, 24 and 36 month follow-ups Primary endpoints: safety and efficacy 70 patients, enrollment completed Sept day, 1, 3, 6, 12, 24 and 36 month follow-ups Primary endpoint: closure w/o use of sedation, tumescent anesthesia or compression stockings 242 Patients, enrollment completed Sept day,1,3,6,12 months and 2,3 year follow-ups Primary endpoint: non-inferior to RFA in GSV closure Secondary endpoint: superiority in reduction of post procedural pain and bruising 1 Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine Proebstle, T et al., The european multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. JVS: Venous and Lymphatic Disorders 2014; Accepted for publication. 3 Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, 2014.

40 Study Design Endpoints Closure Rates 1 Prospective, non-randomized single center study. To evaluate safety, efficacy and performance of the VenaSeal closure system for the treatment of incompetent saphenous veins. 38 patients enrolled. Safety: Rate of serious adverse events. Efficacy: Treatment success defined as complete occlusion of the treated vein segment using duplex ultrasound imaging. 1-Year: 92% 2-Year: 92% 3-Year: 92% 1 No adjunctive treatments for 6 months Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.

41 Study Design Endpoints Prospective, non-randomized, multicenter study. To evaluate safety, efficacy of the VenaSeal closure system for the treatment of refluxing great saphenous veins. 70 patients enrolled. Follow-up assessments at 48 hours, 1, 3, 6, and 12 months. Duplex ultrasound closure without use of sedation, tumescent anesthesia or compression stockings. Closure Rates 1 6-Months: 94.3% 1-Year: 92.9% 1 No adjunctive treatments for 3 months Proebstle, T et al., The European Multicenter Cohort Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins. JVS: Venous and Lymphatic Disorders 2014

42 Study Design Prospective, randomized 1:1 comparing the VenaSeal system (VSCS) to RFA (ClosureFast catheter). Purpose Demonstrate safety and effectiveness of the VenaSeal closure system (VSCS) for the treatment of lower extremity truncal reflux by showing non-inferiority at three months to RFA using the ClosureFast system. Closure Rates 1 3-Months: RFA: 94.3% VSCS: 98.9% 6-Months: RFA: 94.3% VSCS: 98.9% 1 No adjunctive treatments for 3 months Gibson, K. A Randomized, Controlled Study Comparing Cyanoacrylate Adhesive Embolization With Radiofrequency Ablation For Treatment Of Incompetent Great Saphenous Veins VeClose Study. German Society of Phlebology, 2014.

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