20160226 Confidential Not for distribution atm k Pa

20160226

Confidential Комплаенс Not for distribution Модель Диаметр баллона (мм) atm k. Pa 2. 00 mm 2. 25 mm 2. 50 mm 2. 75 mm 3. 00 mm 3. 25 mm 3. 50 mm 4. 00 mm 4 4 x 10² 1. 93 2. 16 2. 38 2. 65 2. 89 3. 13 3. 37 3. 86 5 5 x 10² 1. 97 2. 20 2. 44 2. 70 2. 95 3. 19 3. 45 3. 94 6 6 x 10² 2. 00 2. 25 2. 50 2. 75 3. 00 3. 25 3. 50 4. 00 7 7 x 10² 2. 03 2. 28 2. 55 2. 79 3. 04 3. 29 3. 54 4. 05 8 8 x 10² 2. 06 2. 31 2. 59 2. 81 3. 07 3. 32 3. 57 4. 10 9 9 x 10² 2. 08 2. 34 2. 63 2. 84 3. 10 3. 35 3. 61 4. 14 10 10 x 10² 2. 10 2. 36 2. 66 2. 86 3. 12 3. 38 3. 64 4. 17 11 11 x 10² 2. 12 2. 38 2. 68 2. 88 3. 14 3. 41 3. 66 4. 19 12 12 x 10² 2. 14 2. 40 2. 70 2. 90 3. 16 3. 43 3. 69 4. 22 13 13 x 10² 2. 16 2. 42 2. 72 2. 92 3. 18 3. 46 3. 71 4. 24 14 14 x 10² 2. 18 2. 45 2. 74 2. 94 3. 20 3. 48 3. 73 4. 26 15 15 x 10² 2. 20 2. 47 2. 76 2. 96 3. 22 3. 50 3. 75 4. 27 16 16 x 10² 2. 23 2. 49 2. 78 2. 98 3. 25 3. 53 3. 77 4. 29 17 17 x 10² 2. 25 2. 51 2. 80 3. 00 3. 27 3. 56 3. 80 4. 31 18 18 x 10² 2. 27 2. 53 2. 82 3. 02 3. 29 3. 58 3. 82 4. 32 NP RBP

Показания к применению (BISHOP) ВV Bi furcated lesion I SR lesion S mall vessel H eavily calcified O stial lesion P re- dilatation Confidential Not for distribution

Пост-дилятация BMS 3. 5 x 14 на 16 атм AVG: 1. 56 mm² AVG: 3. 40 mm² Результат NC и BMS NSE и BMS Confidential Not for distribution

Confidential Дизайн исследования Not for distribution Non-randomized trial (n: 93) All Patients 93 pts (99 lesions) 55 cases NSE only B 15 cases Incomplete treatment due to POBA slippage, further inflation with NSE C 21 cases POBA only A NSE Excluded Cases 2 ( 2) Safety Group 57 ( 62) POBA Efficacy Group 36 ( 37) D D C POBA Slippage NO POBA Slippage 15( 16) 21 ( 21) NSE Slippage No NSE Slippage 1 (2) 51 ( 55) 2 cases NSE Unable to Cross Lesion 3 (3) NSE Slippage No NSE Slippage 1 (1) 13 ( 14) screening cases Drop out 1 case due to dissection at time of POBA, 1 case of POBA failing to cross lesion. Main evaluation criteria Screening NSE Unable to Cross Lesion 1 (1) Safety In-hospital MACE (MACE: death/Q wave MI/CABG) Complication attributed to NSE Efficacy % of slippage Device success

Локализации поражений (N=76) LCX RCA Confidential Not for distribution Type C 10. 5% 25. 0% 30. 3% Целевая артерия Type A 17. 1% Тип АCC /AHA 39. 5% 32. 9% 44. 7% LAD Type B 2 Type B 1

Confidential Результаты Not for distribution Выскальзывание Группа Безопасности Выскальзывание (Нет / Да) Доля P (Fisher's Extract) POBA 21 Lesions / 16 Lesions 43. 2 P < 0. 001 NSE 57 Lesions / 2 Lesions 3. 4 P < 0. 001 Выскальзывание (Нет / Да) Доля P (Fisher's Extract) POBA 0 Lesions / 15 Lesions 100 P < 0. 0001 NSE 14 Lesions / 1 Lesions 6. 7 P < 0. 0001 % % Группа Эффективности % %

Example Case 1 POBA 2. 5 /15 mm 77 y. o. Female #4 PD SAP NSE 2. 5 /13 mm Confidential Not for distribution

Example Case 1 77 y. o. Female #4 PD SAP Confidential Not for distribution POBA 2. 5 x 15 mm Pre-Inflation Location Slippage proximal Slippage Initial inflation Inflation NSE 2. 5 x 13 mm Pre-Inflation Location No slippage

Example Case 2 POBA 3. 0 /14 mm 77 y. o. Female #6 RMI NSE 3. 0 /13 mm Confidential Not for distribution

Example Case 2 77 y. o. Female #6 RMI Confidential Not for distribution POBA 3. 0 x 14 mm Pre-Inflation Location Slippage proximal Slippage Initial inflation Inflation NSE 3. 0 x 13 mm Pre-Inflation Location No slippage

Confidential Публикации Not for distribution Journal of Cardiology 6 3 ( 2 0 1 4 ) 1 9 – 23 New Technique Original Contribution Contents lists available at Science. Direct Journal of Cardiology Efficacy of Lacrosse NSE Using the “Leopard-Crawl” Technique on Severely Calcified Lesions journal homepage: www. elsevier. com/locate/jjcc Kazuhiro Ashida, MD , Ph. D, Taichiro Hayase, MD , Takayuki Shinmura, MD Original article Clinical significance of non-slip element balloon angioplasty for patients of coronary artery disease: A preliminary report Isao Taguchi (MD, Ph. D, FJCC) a, ∗, Michiya Kageyama (MD, Ph. D) a , Tomoaki Kanaya (MD) a , Shichiro Abe (MD, Ph. D) a , Koichi Node (MD, Ph. D, FJCC) b , Teruo Inoue (MD, Ph. D, FJCC) a a b Department of Cardiovascular Medicine, Dokkyo Medical University, Tochigi, Japan Department of Cardiovascular Medicine, Saga University, Saga, Japan i n f o Introduction fact that the DES does not contribute to improvements in long-term prognosis. C Keywords: ‘Stentless’ percutaneous coronary intervention Lacrosse ® non-slip element balloon Drug-eluting stent Restenosis a b s t r a c t Background: Recent advances in drug-eluting stent (DES) technology have succeeded in reducing resteno - sis. However, the use of DES is reportedly equivalent to bare metal stents in terms of long-term survival. In addition, stent materials represent foreign bodies, which if possible should not ideally be left within the patient. On these bases, an investigation was performed into the feasibility of a new approach, ‘stentless’ percutaneous coronary intervention (PCI), using a Lacrosse ® non-slip element (NSE) balloon (Goodman Co. , Ltd. , Nagoya, Japan). Methods and results: In our ‘stentless’ approach, the NSE balloon is used for target lesion dilation in patients with low risk factors and simple target lesions. No stenting was performed once an optimal dilatation result was achieved, as evaluated by intravascular ultrasound (IVUS). In a total of 3 4 0 lesions in 3 0 4 patients, in whom the follow-up study was completed, the ‘stentless’ PCI by NSE balloon alone was achieved in 5 2 lesions (15%). Target lesion revascularization (TLR) was performed for 5 (9. 6%) of the 5 2 ‘stentless’ lesions. In the comparison between the 5 2 ‘stentless’ lesions and the 3 1 DES lesions selected under the statistical matching of the patient profiles and baseline lesion characteristics, the TLR rate (9. 6% vs 6. 5%, p = 0. 616) and late lumen loss (0. 52 ± 0. 26 m m vs 0. 48 ± 0. 21 mm, p = 0. 347) were similar. In the 5 2 ‘stentless’ lesions, IVUS parameters such as vessel area, minimal lumen area, and plaque area at both before and immediately after PCI were similar between the 5 TLR lesions and the 4 7 non TLR lesions. Conclusions: It is believed that the ‘stentless’ approach is applicable even in the DES era. © 2 0 1 3 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved. Abbreviations CAG = coronary angiography IVUS = intravascular ultrasound LAD = left anterior descending artery LAO = left anterior oblique LCX = left circumflex coronary artery OCT = optical coherence tomography PCI = percutaneous coronary intervention POBA = plain old balloon angioplasty RCA = right coronary artery . 3 se 0 1 l. U 2 na M P so H e r ht r P rig F o opy a r t i c l e Article history: Received 2 0 November 2 0 1 2 Received in revised form 3 1 May 2 0 1 3 Accepted 1 9 June 2 0 1 3 Available online 2 9 July 2 0 1 3 Ab. STr. ACT: Calcified lesions often encounter difficulties associated with stent delivery and underexpansion. Lesion preparation of calcified lesions prior to stent implantation is important to facilitate stent delivery and provide concentric stent expansion. The Lacrosse NSE, a balloon catheter with 3 nylon elements, provides an efficacious scoring effect when used for predilatation of calcified lesions. Although bench testing on a calcified model verified that Lacrosse NSE and other scoring catheters provide a greater scoring effect compared to conventional plain old balloon angioplasty, delivery to target lesion location using standard delivery techniques for severely calcified lesions is typically more prob- lematic. One method for overcoming the obstacles faced by difficult delivery is use of the “leopard-crawl” technique. This technique uses a low inflation pressure to create a wedge into the calcification and then subsequently advances the catheter during balloon deflation to facilitate catheter delivery across the stenosis. This technique is well suited for the Lacrosse NSE due to the unique catheter design. We hereby report on the initial clinical use of the leopard-crawl technique for facilitating catheter delivery in cases of severely calcified lesions in which standard delivery was unsuccessful, while creating an efficacious scoring J INVASIVE CARDIOL 2013; 25(10): 555 effect into 564 the calcified lesion that reflects the results of bench testing. Key words: calcified lesion, leopard-crawl technique, intravascular ultrasonic imaging, CT angiography The scope of cases treated with PCI has increased with fur- ther advances in medical devices and techniques. However, treatment of calcified lesions by PCI remains problematic, 1 -3 with difficulties associated with stent delivery, underexpansion, and asymmetric expansion resulting in worse patient prognosis. Therefore, it is considered that predilatation to create 4, multiple scoring effects into the lesion prior to stenting 5 leads to better stent expansion. Recently, the novel Lacrosse NSE catheter (Goodman Co, Ltd) has become commercially available. The catheter con- tains three triangular nylon elements (width, 0. 014˝; height, 0. 015˝) that are free floating on the outside of the balloon surface, and attached proximal and distal to a 13 mm balloon length. Dilatation using a Lacrosse NSE creates a scoring effect dilative effect of various types of commercially available scoring balloons on fully circumferential calcified models. Unfortunately, current designs of scoring balloons result in reduced functionality in regard to delivery in comparison to conventional balloons, and difficulties associated with delivery and lesion crossability of scoring catheters occur in a clinical setting. 6 The Lacrosse NSE elements are attached distal to the balloon location, and for instances whereby the catheter is un- able to cross lesion location, a “leopardcrawl” technique can assist in facilitating device delivery. The efficacy of the leopard- crawl technique in crossing calcified lesions in a clinical setting is also Methods further addressed. Testing method for identifying scoring effect. Twelve cy- lindrical tubes (inner diameter, 3. 0 mm; thickness, 0. 7 mm; approximate length, 7. 1 mm) comprised of New Diastone Yel- low (dental stone; Morita Co, Ltd) (Figure 1) and covered by silicone tubing (thickness, 1. 0 mm) were used to represent a calcified lesion (Figure 2) (calcified models were provided by Goodman Co, Ltd). Three catheters of each of the following devices were dilated within the calcified models: 3. 5 x 10 mm Powered Lacrosse noncompliant balloon (Goodman Co, Ltd); 3. 5 x 13 mm Lacrosse NSE scoring balloon; 3. 5 x 10 mm Flextome cutting balloon; and 3. 5 x 10 mm Scoreflex (Orbus Neich

Confidential Leopard Crawl Technique Not for distribution One of the special features required for this type of delivery method is the non-balloon zone of the distal catheter tip. The unique design of the NSE ensures that the elements are connected both distal and proximal to the balloon component and are not fixated to the balloon body. Under low inflation pressure a small gap is generated between the balloon shoulder and elements and provides space for the catheter body to move into upon deflation of the body and folding of the elements into the pre-inflation position. 1. Balloon component may not be able to cross target lesion (advancing the catheter may result in the GC becoming disengaged). 4. Repeat steps 2 and 3 until the catheter has successfully crossed the lesion. 2. Inflate the NSE at low inflation (4 -6 atm). During inflation remove any slack in the guidewire and reposition the GC. 5. Using normal inflation pressures, dilatate the lesion from distal to proximal location. 3. During deflation, further advance the catheter into the target lesion. 6. Undertake a push test of the catheter through the stenosis and further dilatate any location that incurs resistance.

Техника Leopard Crawl Confidential Not for distribution