theoretical background and first real world results Dr. K. Amendt Center of Vascular Medicine „Oberrhein“ (Mannheim – Speyer) Clinic for Internal Medicine I: Angiology, Cardiology and Subsequent Complications of Diabetes mellitus Diakonissenkrankenhaus Mannheim Germany Academic Teaching Hospital Clinical Medicine Mannheim University Heidelberg K.Amendt@diakonissen

• I have the following potential conflicts of interest to report: • Advisory Board and Consultant: • BAYER AG • Boehringer Ingelheim • UCB Pharma • B. BRAUN

Free floating rubber band ? Cave: data mainly from healthy volunteers (MRT) and cadavers less angiographically (angio MRA) Mod. Nach W. Meichelboeck, Chir. Vasculaire, Nov. 26-28, 2009 Paris

Long stents early result Biomechanical stress Conformability missmatch: arterial wall- stent late result Stent- fracture Intimal hyperplasia Restenosis: LLL Occlusion Re-do Costs

Accepted problems with Stenting 1. changes in biomechanical properties and chronical inflammation of stented segement /artery  stent fracture  intimal hyperplasia  late lumen loss problems increase with length of treated vessel segment = Stent- disease long lesion  long stent  problem  „leave nothing behind“ ©

Concept of focal stenting  Calcified lesions demand ongoing mechanical stabilisation of initial balloon-result: mandatory scaffolding  DEB, Tack-it, BVS and DBVS alone do not solve this problem  There is still a need for permanent scaffolding:  long lasting  with a reduced mass of foreign body (as few as possible)  = focal- spot / taget- stenting

full lesion coverage focal stenting Standard procedure

The concept of focal stenting Custom length stent acute result angiographic control 27d after implantation

radial force / stentdesigns Newton (N) Design - Stent-Größe Conclusion: 1. Animal experiments show technical feasibility of the multi stent delivery system (MSDS): Multi-Loc. 2. Exact anatomically controlled implantation of short stents is possible. 3. Short stents in actively bended arterial segments do not fracture (0 vs 5). 4. Patency of arterial segments after stenting with 4-5 short individual stents is superior to single long stent implantation in all animals.

First real world experiences ( not really results)  Popliteal artery © K. Amendt

prolonged woundhealing after minor amputation

First real world experiences ( not really results)  Femoro-Popliteal Artery long lesion

JR PRIMARE DIA< hipai-ItttQrcIprprepii -rr fur f^rimare diagnos •edtcU'pn m i , , _

PRIMARE DIAGNCfT FUR PRIMARE DIAHT FUR PRIMARE DIAGT FUR PRIM, eclictio.n , n~~rm tirrln r ,ik, rjii-tign

after 10 weeks: No fractures ML-6 2HT FUR PRIMARE C IHT FUR PRIMARE DIAGNOS

No restenosis (LL) No edge phenomenon ML-6 © K. Amend

First real world experiencs N: 30 pat.; LL: 4-30 cm; LLav:12 cm; M-L: 141; M-L/pat.: 2-12 (4.7); M-L/cm LL: 0,41; LL /ML: 2,46 cm > ML-stents are safe: technic. succ: 100% exact anatomically controlled release no stents lost no conversion to standard stenting no acute occlusion > radial force in severely calcified lesions: no recoil, no fracture > biomechanical properties of artery: unchanged Cave: release stents in an optimal prepared „bed“ = predilatation: 0-POBA/DEB = 0 lumen artery = 0-stent = 0 lumen artery (no oversizing) post stent dilatation = to align longitudinal axis

Clinical Trials.gov A service of the U.S. National Institutes of Health Find Studies About Clinical Studies Submit Studies Resources About This Site Home > Find Studies > Search Results Text Size ▼ 3 studies found for: locomotive Modify this search | How to Use Search Results List By Topic On a Map Search Details + Show Display Options cp Down|oadjfc Subscribe to RSS □ Include only open studies □ Exclude studies with Unknown status Rank Status Study "All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC forflOw liMiting Outcomes Condition: Peripheral Arterial Occlusive...

Further developments Test 15.09.17 ( 115 y , 115 y) Unnamed Coro 3040 Nitinol ring outer sheath Multi-Loc stent-body Closed cell design Zoom::178% Winkel: 0 B: 71/151 Series: 9 JPEG Lossless:!-! on -hieranchi NICHT FOR PRIMARE DIAGNOSTIK StOrdeipreuiutiui i

open cell desig 30 Recommended introducer sheath 6F / Maximum guide wire .035 inch VascuFlex 3 LOC 3-LOC Product Specifications open cell desig Application Device 6F / 80 cm Nominal Length mm Application Device 6F i 130 cm Nominal Length mm B| BRAUN SHARING EXPERTISE Recommended introducer sheath 6F / Maximum guide wire .035 inch

theoretical background and first real world results Dr. K. Amendt Center of Vascular Medicine „Oberrhein“ (Mannheim – Speyer) Clinic for Internal Medicine I: Angiology, Cardiology and Subsequent Complications of Diabetes mellitus Diakonissenkrankenhaus Mannheim Germany Academic Teaching Hospital Clinical Medicine Mannheim University Heidelberg K.Amendt@diakonissen