Pantera Lux Device Description and Overview of Clinical Data

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1 Pantera Lux Device Description and Overview of Clinical Data Ralph Tölg, MD Herzzentrum Segeberger Kliniken GmbH Bad Segeberg, Germany

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company BIOTRONIK Abbott Vascular, BIOTRONIK, enverdis none none none none none

3 Pantera Lux 1 Paclitaxel Releasing Balloon Drug Matrix Coating Pantera Lux Paclitaxel (3.0 µg/mm 2 ) Anti-proliferative, lipophilic and allow fast absorption Excipient Guarantees high bioavailability of paclitaxel at target lesion for rapid drug absorption by tissue BTHC 2 Keeps paclitaxel in micro-crystalline structure Degrades to citric acid and alcohol Pantera Semi-compliant, good deliverability and flexible balloon folds to protect drug Balloon platform 1 Manufactured and distributed by BIOTRONIK 2 Butyryl-tri-hexyl citrate, known as additive in blood bags to keep the plastic malleable Product is CE marked. Not for sale in the U.S.

4 Pharmacokinetics show paclitaxel present in vessel out to 7 days Pig coronary artery paclitaxel concentrations (µg/g tissue) 30 minutes N = 6 2 hours N = 6 8 hours N = 8 1 day N = 6 3 days N = 6 7 days N = 6 Dist Mid Prox Time after balloon dilatation Radke M, EuroIntervention 2011 Oct 30;7(6): 730-7

5 Pantera Lux clinical study program PEPPER FIM N=81 DES- & BMS-ISR Enrolment and 1 y FUP completed DELUX Registry N=1 000 All comers Enrolment and 6 mo FUP of 600 patients completed BIOLUX RCT RCT vs DES N=210 ISR Enrolment to start 2012 BIOLUX-I Registry N=35 Bifurcation Enrolment ongoing BIOLUX P-I FIM, RCT vs POBA N=60 SFA* Enrolment complete BIOLUX P-II FIM, RCT vs POBA N=60 BTK* Enrolment to start Q *Passeo-18 Lux, SFA/BTK product, approval pending

6 Pantera Lux local national trials PAPPA-pilot NLD N=100 AMI Enrolment and 1 mo FUP completed Monzino registry ITA N=139 ISR Enrolment and 3 mo FUP completed PEARL RCT vs POBA CAN N=76 Enrolment ongoing in bifurcation SARPEDON HKG N=40 Bifurcation Enrolment ongoing

7 Paclitaxel REleasing Balloon in Patients PresEnting with In-Stent Restenosis FIM Trial Design Prospective, multi-center, nonrandomized, European clinical trial of the Pantera Lux Paclitaxel Releasing Balloon Objective To evaluate the safety and efficacy of the Pantera Lux in patients with BMS and DES in-stent restenosis in coronary arteries Principal Investigator Christoph Hehrlein, MD University Medical Center Freiburg, Germany 81 patients with one target lesion enrolled between August 2009 and April 2010 in 9 clinical sites in Germany, Poland and Denmark Lesions pre-dilated with an uncoated balloon and treated with one Pantera Lux. 3 month dual antiplatelet therapy administered. Clinical follow-up at 1 month Clinical & angiographic follow-up at 6 months Clinical follow-up at 12 months Clinicaltrials.gov, NCT

8 PEPPER 6- and 12-Month Results Angiographic results 1 Late Lumen Loss, In-stent 2 Late Lumen Loss, In-segment 3 6-month All 0.07 ± 0.31mm 0.03 ± 0.32mm Clincial results 6-month 12-month All BMS 4 DES 4 All BMS 4 DES 4 Major Adverse Cardiac Events 5 5 (6.5%) (11.8%) 2 7 Cardiac death Non-fatal MI 1 (1.3%) (1.3%) 1 - TLR (clinically driven) 3 (3.9%) (9.2%) 1 6 TVR 7 (clinically driven) 1 (1.3%) (1.3%) Assessed by independent core lab 2 In-stent length defined as restenotic area where the balloon was dilated (from shoulder to shoulder) 3 In-segment length defined as in-stent plus 5mm proximal and distal 4 Last layer of metal placed before DEB treatment 5 Hierarchical MACE, adjudicated by CEC/DSMB 6 Within 24 hours after procedure 7 Non-TLR

9 Drug REleasing Pantera LUX PTCA Balloon Catheter Registry (DELUX) Design Prospective, multi-center, non-randomized, international, non-interventional registry of the Pantera Lux Paclitaxel Releasing Balloon Objective Evaluation of the safety and efficacy of the Pantera Lux for coronary arteries in daily clinical practice Principal Investigator Ralph Tölg, MD Herzzentrum Segeberger Kliniken Bad Segeberg, Germany 601 patients with 647 lesions enrolled between March 2010 and December 2010 in 52 sites in 11 countries Lesions treated with one Pantera Lux. Pre-dilation recommended with an uncoated balloon at least 5mm shorter than study device. Clinical follow-up at 1 month Clinical follow-up at 6 months Clinical follow-up at 12 months Clinicaltrials.gov, NCT

10 DELUX Indications 1 100% 80% 60% 40% 20% 0% 88.0% 10.0% ISR De novo 46.8% Stent type 0.9% BMS-ISR DES-ISR Unknown 52.3% 26.6% Vessel size 3.1% 70.3% Small: mm Normal: > mm Unknown 1 2% unknown

11 DELUX 6-Month Clinical Results 15% 10% % 0% MACE 1 All death 2 MI (non-fatal) TLR (clinically driven) TVR / non-tlr (clinically driven) Total BMS-ISR DES-ISR De novo Stent Thrombosis (definite/probable/possible) 1.2% Acute 0.2% Sub-acute 0.5% Late 0.3% Time point unknown 0.2% 1 Hierachical MACE, composite of all death, non-fatal MI and clinically driven target vessel revascularization (TVR) 2 10 cardiac, 6 non-cardiac and 2 unknown death

12 Pantera Lux in STEMI: PAPPA-pilot Inclusion of 100 patients with primary PCI in STEMI: Mean age 60,2 years Male 74% Diabetes 11 % DEB only strategy Provisional stenting 1 with BMS as bailout if: Residual stenosis >50% Dissection with threatening vessel closure 1-month clinical results N=100 MACE 3% Cardiac death 1% MI 0 TLR 2% 1 41% cross-over to DEB + BMS van der Schaaf et al., presented at TCT 2011

13 Conclusions The Pantera Lux clinical program has enrolled beyond patients to date Treatment in ISR has been proven to be effective with revascularization rates as low as 3.9% in a real world setting First clinical results outside the ISR indication show low revascularization rates in de novo lesions, including AMI patients Further evidence for ISR, bifurcations as well as lower limb indications is currently collected by the comprehensive Pantera Lux clinical program

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