PK Papyrus Covered coronary stent system Indicated for

PK Papyrus Covered coronary stent system Indicated for acute coronary artery perforations CRT 2018 William A. Gray MD System Chief for Cardiovascular Services Main Line Health Wynnewood PA

Disclosures I have no relevant financial relationships

Indicated for acute coronary artery perforations Perforation is a rare complication of PCI (0. 3% of PCI) 1 Type III perforations are most severe and associated with high rate of tamponade and death 2: Type 1 2 N Tamponade Emergency CABG Death I Extraluminal crater without extravasation 13 8% 15% 0% II Pericardial or myocardial blush without contrast jet extravasation 31 13% 10% 0% III Extravasation through frank (≥ 1 mm) perforation 16 63% 19% CS Perforations into an anatomic cavity chamber (CS=cavity spilling) 2 0% 0% 0% Witzke CF et al, J Invasive Cardiol. 2004 Jun; 16(6): 257 -301. Ellis, S. G. et al. Circulation 1994(90): 2725 -30.

Management of coronary perforations Treatment strategy for perforations may include the following: § Contralateral access and 2 nd guide catheter § Immediate occlusion of extravasation by POBA or perfusion balloon § Pericardiocentesis if tamponade § Reversal of heparin anticoagulation § Coil/microsphere/glue embolization § Covered stent implantation § Timed echos post procedure § Emergency CABG

Covered single stent design allows for low crossing profile and 5 F guide catheter compatibility Graftmaster 2. 8/16 Sandwich design PK Papyrus 3. 0/15 Covered single stent design 23% reduction Crossing profile [mm diameter] Guide catheter compatibility* 1. 63 6 F Data on file at BIOTRONIK; * Ø 2. 5 -4. 0 mm 1. 19 1. 25 5 F

High flexibility and low crossing profile for exceptional deliverability – allowing you to seal perforation with confidence Expect PK Papyrus to deliver like a conventional stent Bending stiffness of crimped stent PK Papyrus 3. 0/15 58% reduction Track Force in coronary artery model [N] 53% reduction in maximum track force Jostent Graftmaster 3. 0/16 PK Papyrus 3. 0/20 Jostent Graftmaster 3. 0/19 PRO-Kinetic Energy 3. 0/20 Data on file at BIOTRONIK

Proprietary BIOTRONIK covered single stent design Polyurethane membrane, capable of sealing vessel perforations PK Papyrus Electrostatic forces spin polyurethane fibers onto the stent surface, creating a membrane only 90 µm thick - as thin as a butterfly’s wing Polyurethane fibers (2000 x) PK Papyrus (50 x)

Dr. Thieme, Berlin: Coronary type III perforation in the mid LAD Patient history 75% ostial and 85% mid to distal LAD stenosis Stent implantation Second Biomatrix Neo. Flex created an ~5 mm long perforation in stent overlap area Treatment Balloon inflation (2 x 60 sec. ) Protamine injection Emergency pericardiocentesis Baseline: 75% ostial and 85% mid LAD stenosis Type 3 perforation in stent overlap zone PK Papyrus implantation Final result with TIMI 3 flow PK Papyrus passage of ostial stenosis and proximal stent without complication Delivery behavior similar to a normal coronary stent Final result Patient discharged without further complications 7 days post procedure

Coronary covered stent market Competitor Overview Matrix Device name Sandwich design PK Papyrus Be Graft Aneu. Graft DX Graft. Master Direct-Stent Graft BIOTRONIK Bentley Inno. Med ITGI Medical Abbott Vascular In. Situ Technologies Polyurethane e. PTFE Equine pericardium e. PTFE 5 F 5 F 6 F 6 F 6 F L 15 - 26 8 - 40 10 – 38 16 – 26 10 – 40 ø 2. 5 - 5. 0 2. 5 - 6. 0 2. 8 - 4. 8 2. 5 - 6. 0 Manufacturer Cover material Recommended guide catheter* Available size range (mm) Single stent design *1 french size up for stent diameters larger 4. 0 mm (Aneu. Graft for stent diameters larger 3. 5 mm)

Conclusion Orsiro / PRO-Kinetic Energy stent platform A thin strut cobalt-chromium platform with exceptional deliverability Innovative polyurethane membrane Unique manufacturing method allows for an ultra thin membrane capable of sealing vessel perforations Single stent design The proprietary BIOTRONIK covered single stent design enables a 58% higher flexibility and a 20% lower crossing profile* Deliverability A high performing platform with an ultra thin membrane to deliver more like a conventional stent *Data on file at BIOTRONIK, compared to Jostent Graftmaster