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Descripción: Manual de usuario para equipos de limpieza y prueba de inyectores Launch.
Your 21-Day Launch Plan
Moving Towards Biomimicry BioMime Morph SES BioMime Aura SES BioMime SES NexGen Co--Cr Co
BioMime Morph Sirolimus Eluting Tapered Coronary Stent System
Identifying Unmet Clinical Need Research premise for BioMime Morph – Morph – Sirolimus Eluting Tapered Coronary Stent System System
based on two primary observations from routine PCIs1. Ana Anatomic omical al sha shape pe of vesse essels ls 2. Proc Proced edur ural al con conce cern rnss assoc associa iatted with with stenting stenting of long diffused lesions
is
Anatomical Shape of Vessels
•
•
Right coronaries are generally tubular & nontapering vessels Left coronaries generally give off branches & taper –
The vessels usually tend to taper to the tune of 10-15% per 30mm of vessel length
Procedural Concerns •
g n i l a e h d e y a l e D
Procedural concerns with long diffused lesion stenting –
Long diffused lesions need to be treated with multiple stents
–
Multiple stents need to be overlapped
–
Concerns with overlapping DES•
Vessel rigidity – make the vessel rigid due to excess metal
•
Fracture – are more prone to fracture due to rigidity
•
Restenosis – cause higher vascular injury leading to restenosis
•
Drug overdose – have twice the dose leading to delayed healing
•
•
•
•
Polymer inflammation – have twice the polymer dose leading to polymer inflammation Aneurysm – excessive drug dose may lead to aneurysms Side branch jailing – excess un-organized metal may jail important side branches Over radiation – multiple stenting procedure take longer time and expose the operator to over radiation
•
Contrast media – multiple stenting procedure involves more contrast media
•
Cost – multiple DES cost more
Identifying the Unmet Clinical Need Anatomical
•
•
Right coronaries are generally tubular, non-tapering
Left coronaries usually taper after each branch
Procedural
PCI
g n i l a e h d e y a l e D
Concerns with Multiple Stenting of Long Lesions Vessel rigidity Fracture Restenosis Aneurysm Drug overdose Polymer inflammation Side branch jailing Over radiation Excess contrast Cost • • • • • • • • • •
Limitations of Current Treatment •
•
In the present scenario, to treat lesions >48mm one is compelled to use two or more stents Anatomical mismatch between currently available cylindrical stents with natural taper of coronary arteries –
Higher distal diameter has a propensity to cause distal vessel dissection
Limitations of Current Treatment
Long diffused lesion of LAD Artery requiring 2 overlapping stents
Cylindrical artery at the stented site and an abrupt tape distal to stent
The Solution – BioMime Morph BioMime Morph System Components •
•
•
•
The Stent – Classical BioMime hybrid design which has an intelligent mix of closed cells at the edges and open cells articulating along the length of stent The Drug – Clinically established anti-proliferative – Sirolimus (dose 1.25μg/mm2) The Polymer – Biocompatible, biodegradable co-polymer combination of PLLA+PLGA – BioPoly The Delivery System – A newly designed tapered PTCA Balloon Catheter with half size diameter tapers & a reinforced shaft system for enhanced flexibility & effortless deliverability D2
D1 D1 > D2 Difference of 0.5 mm
Advantage BioMime Morph •
•
Provide anatomical correct treatment –
Tapered stent for tapered vessels such as LAD / LCX
–
Regular stent for non-tapered vessel such RCA
A single long stent to cover lesions upto 56mm –
•
Avoid overlapping DES
Better vessel wall coverage due to uniform stent design –
High conformability & no mallaposed struts
–
Reduced blood flow perturbances & shear stress
Advantage BioMime Morph •
Optimal metal to artery ratio –
–
•
Uniform drug-polymer distribution for predictable healing and to minimise neo-intimal hyperplasia (restensosis) Reduced propensity for aneurysm
Robust design elements to ensure high stent flexibility without any risk of fractures
•
No geographical miss due to precision in stent dimensions
•
Procedural convenience of using a single stent –
Reduced procedural time
–
Less exposure to radial (benefits operator)
–
Reduced use of contrast media (benefits patient)
–
Lower costs than multiple DES
Stent Architecture •
•
•
•
Cobalt chromium (L605) platform with 65µm strut thickness. Hybrid cell design comprising of an intelligent mix of open and close cells resulting in excellent radial strength with a high flexibility. Unique strut width variability that ensure a <3% recoil and 0.29% foreshortening Special electro-polishing technique eliminates surface nickel oxides SEM image of crimped BioMime Morph at 50x
Closed cell at edges
Open cell in mid - segment
Hybrid design
High Radial Strength •
BioMime Morph demonstrates comparable radial strength with mean collapse pressures of 1.1bar which is on the higher side amongst 14 predicate devices tested
Red dot signifies BioMime Morph mean values
High Radial Strength •
Competitive radial strength combined with high flexibility with ultra-low strut thickness 1.6 ) s r a B ( h t g n e r t S l a i d a R
1.4
1.2 1 0.8 0.6 0.4 0.2
65µ n g i s e d d i r b y H
65µ
65µ
n g i s e d d i r b y H
s l l e C n e p O
81µ
s l l e C n e p O
80µ
s l l e C n e p O
90µ
s l l e C n e p O
0 BioMime
BioMime Morph
Coroflex blue
Vision
Prokinetic
Driver
Choice for Co-Cr L605 & RO •
•
•
Stronger than S/S – allows for mfg of thinner struts while maintaining radial strength Denser than S/S – Higher density allows for thinner struts with good RO More MRI compatibility – Since Fe content is negligible (<1%), Co-Cr is nonferromagnetic as compared to S/S
45% stronger than S/S
Excellent Radiopacity
Recoil & Foreshortening •
•
•
Bench testing demonstrates a <3% recoil and 0.29% foreshortening Closed-cells on the edges lend their radial strength to the entire scaffold Strut-width variability across the design geometry ensure retention of radial strength Variable width
Y-connector
S-link
Mirror polish
Bench Performance Pushability •
BioMime Morph demonstrates lower tracking force (mean ultimate force value 0.73N) during pushability test in comparison to 17 predicate devices during the bench test
Trackability •
BioMime Morph demonstrates lowest tracking force (mean ultimate force of 2.89N) amongst 7 predicates during benching testing for trackability
Dislodgment Force •
BioMime Morph demonstrates highest mean stent dislodgement force of 7.5N in comparison to 12 predicates.
Excellent Side Branch Access
The area of the largest circle circumscribable in the cell of the stent expanded to the nominal diameter: Tc = 0.71 mm2
The expanded BIOMIME Morph 3.0-2.5 x 30 mm stent after side branch expansion Expanded cell perimeter that ensures side branch access: K SBA = 11.29 mm Expanded cell area that ensures side branch access: TSBA = 8.00 mm 2
Unique Balloon Construction •
BioMime Morph maintains a highly controlled balloon overhang of <0.5mm with short tapered shoulders which have a propensity to minimize balloon related arterial injury
Note the narrow balloon shoulders which assist in minimizing balloon related vessel injury
Complete expansion
Right Drug – Sirolimus & Loading •
•
Sirolimus is an ideal choice considering that it acts on the common final pathway of cell division cycle without exceptional risk of necrosis induction BioMime Morph has 1.25µgm/mm2 of Sirolimus loading on stent Stent Length (mm)
Drug Loading (µ g) Stent Daimeter (mm) 2.75-2.25 3.00-2.50 3.50-3.00
30 40
143 191
187 250
187 250
50
239
312
312
60
286
375
375
Pharmacokinetics
@100% of drug elutes in 30days
Biopoly – Biodegradable Polymer
•
•
•
•
BioPoly is Meril’s propriety bio-degradable co-polymer formulation is a 1:1 mix of PLGA & PLLA
Before inflation
The principle mode of BioPoly TM degradation is hydrolysis via mass loss & by products are excreted as CO2and H2O via Kreb’s cycle The material offers uniformity in stent coating & thin coating of <2µm is possible Does-not web, crack, lump or on stent or balloon surface
After inflation
Technical Specification Stent System •
Stent Material
:
Cobalt chromium L605
•
Strut Thickness
:
65 µm
•
Stent Diameter
:
2.75-2.25, 3.00-2.50, 3.50-3.00 mm
•
Stent Lengths
:
30, 40, 50, 60 mm
•
Mean Recoil
:
3%
•
Mean Foreshortening
:
0.29%
Drug/Polymer •
Drug
:
Sirolimus
•
Equivalent Drug Dose
:
1.25 µgm/mm2 of stent surface area
•
Polymer
:
Biodegradable; biocompatible (PLLA+PLGA)
Technical Specification Delivery System •
Delivery System
:
Rapid Exchange
•
Stent Diameter (mm)
:
Crossing Profile (mm/inches)
2.75-2.25
0.93/0.037”
3.00-2.50
0.99/0.039”
3.50-3.00
1.03/0.040”
•
Usable Catheter Length
:
142 cms
•
Balloon Characteristics
:
Semi-compliant
•
Balloon Overhang
:
< 0.5 mm
•
RO Markers
:
2 – Platinum-Iridium
•
Nominal Pressure
:
9 ATM
•
Rated Burst Pressure
:
14 ATM
•
Shaft Outer Diameter
:
Proximal 2.13F; Distal 2.7F
•
Guide Catheter Compatibility
:
5F (Min. I.D. 0.056” / 1.42 mm)
•
Max. Guide Wire
:
0.014” (0.36 mm)
Ordering Information 12 SKUs to choose from! Dia / Length
30mm
40mm
50mm
60mm
2.75-2.25 mm
BIM27525030
BIM27525040
BIM27525050
BIM27525060
3.00-2.50 mm
BIM30025030
BIM30025040
BIM30025050
BIM30025060
3.50-3.00 mm
BIM35030030
BIM35030040
BIM35030050
BIM35030060
Code Cracker BIM27522530 Length BioMime Morph
Diameter
BioMime Morph – Sirolimus Eluting Tapered Coronary Stent System
World’s first & only tapered coronary DES DCGI & CE approved
BioMime Morph in Clinical Practice BioMime Morph in RCA • • • • •
52y/M with h/o exertion chest pain NYHA class II since 1 week Known diabetic and hypertensive ECG – normal sinus rhythm Echo – normal LV function TMT – positive at 8 METS
BioMime Morph in Clinical Practice Diffused RCA Lesion
Guide wire advanced
BioMime Morph in Clinical Practice Pre-dilatation
BioMime Morph 2.75-2.25x60
BioMime Morph in Clinical Practice BioMime Morph 2.75-2.25x60
Final Result
BioMime Morph in Clinical Practice BioMime Morph in LAD • •
• • •
67y/M with typical chest pain since 1 hour Rapidly deteriorated into cardiogenic shock within 30mins of admission Known hypertensive Normal sinus rhythm Echo showed concentric LVH
BioMime Morph in Clinical Practice Diffused LAD Lesion
Guide wire advanced
BioMime Morph in Clinical Practice BioMime Morph 3.50-3.00x60
