The possibilities are endless.
`
`Product Catalog
`
`w w w . g u i d a n t . c o m
`
`
`Page 1
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`GUIDANT CORONARY STENT SYSTEMS
`
`CORONARY GUIDE WIRES
`
`CORONARY GUIDING CATHETERS
`
`CORONARY DILATATION CATHETERS
`
`ACCESSORIES
`
`DIRECTIONAL CORONARY ATHERECTOMY
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
`
`
`Page 2
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`O R D E R I N G I N F O R M A T I O N
`
`R e t u r n P o l i c y
`1. Guidant Corporation’s Vascular Intervention division will accept return of any undamaged and
`unused standard catalog item within 90 days of invoice date. Defective product can be returned
`at any time, with an Authorized Return Goods Number (RGA).
`2. Returned product is subject to examination for acceptable condition or alleged defects.
`3. Acceptable returned product will be credited to customer account subject to a restocking fee.
`4. A Returned Goods Authorization Number is required for all returns and replacements.
`This number can be obtained by calling your account representative, or Customer Service at
`800 227-9902.
`5. The RGA Number must be clearly marked on the outside of all boxes returned. A copy of the
`packing slip and/or Purchase Order Number should be included with the merchandise
`6. Send non-complaint returns to:
`42301 Zevo Drive
`Suite E
`Temecula, CA 92590
`
`A biohazard box is required for all complaint returns. This box can be obtained by calling your
`account representative, or Customer Service.
`
`Send complaint returns to:
`26531 Ynez Road
`Temecula, CA 92591
`
`S h i p p i n g P o l i c y
`Guidant Corporation’s Vascular Intervention division offers a variety of shipping options, including
`overnight delivery. All shipment charges are paid by Guidant. Please specify your shipping preference
`when placing your order with Guidant Customer Service Representatives.
`
`WARNING: Manufactured with CFC-113, a substance which harms public health and environment by
`destroying ozone in the upper atmosphere.
`
`Guidant Corporation’s Vascular Intervention division is diligently working to eliminate the use of
`CFC-113 in the manufacturing process.
`
`
`Page 3
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`CORONARY STENT SYSTEMS
`
`
`Page 4
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`Small Vessel
`
`Small vessel stents
`
`combine low profiles
`
`with a flexible stent
`
`design specifically for
`
`treatment of vessels
`
`that are 2.0 mm
`
`to 2.5 mm in size.
`
`AT T R I B U T E S
`• Thinner struts for increased
`flexibility and larger lumens
`
`• Low system profiles for excellent
`deliverability and crossability
`
`• Noncompliant balloon for
`controlled growth
`
`*ML PIXELTM is indicated for patients presenting
`with abrupt or threatened abrupt closure.
`
`Workhorse
`
`The flexibility,
`
`conformability and
`
`deliverability of
`
`workhorse stents
`
`make them ideally
`
`suited for the majority
`
`of cases.
`
`AT T R I B U T E S
`• Low profiles for easy lesion access,
`enhanced track and stent recross
`
`• Clinically proven stent pattern
`designed to maintain vessel shape
`in tortuous anatomies while providing
`optimal scaffolding
`
`• Minimal balloon overhang to reduce
`balloon interaction outside of the
`stent upon expansion
`
`Large Vessel
`
`AT T R I B U T E S
`
`• Low unsupported surface area and
`high metal-to-artery ratio for excellent
`scaffolding in large native vessels and
`saphenous vein grafts
`
`• High radial strength to minimize recoil
`
`The scaffolding and
`radial strength provided
`by large vessel stents
`make them a superb
`fit for large native
`coronary arteries and
`saphenous vein grafts.
`
`
`Page 5
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`C O R O N A R Y S T E N T
`
`S Y S T E M S
`
`GUIDANT CORONARY STENT SYSTEMS - Cobalt Chromium
`SMALL VESSEL
`MULTI-LINK MINI VISION™ OTW Coronary Stent System
`
`MULTI-LINK MINI VISION™ RX Coronary Stent System
`WORKHORSE
`MULTI-LINK VISION® OTW Coronary Stent System
`
`MULTI-LINK VISION® RX Coronary Stent System
`
`GUIDANT CORONARY STENT SYSTEMS - Stainless Steel
`SMALL VESSEL
`MULTI-LINK OTW PIXEL® Coronary Stent System*
`
`MULTI-LINK RX PIXEL® Coronary Stent System*
`WORKHORSE
`MULTI-LINK OTW ZETA® Coronary Stent System
`
`MULTI-LINK RX ZETA® Coronary Stent System
`LARGE VESSEL
`MULTI-LINK OTW ULTRA™ Coronary Stent System
`
`MULTI-LINK RX ULTRA™ Coronary Stent System
`
`*ML PIXEL® is indicated for patients presenting with abrupt or threatened abrupt closure.
`
`
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
`
`
`Page 6
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`C O R O N A R Y S T E N T
`
`S Y S T E M S
`
`.014" maximum
`guide wire
`diameter
`
`List
`Price
`($)
`
`$2,150
`$2,150
`$2,150
`
`$2,200
`$2,200
`$2,200
`
`$2,225
`$2,225
`$2,225
`
`$2,260
`$2,260
`$2,260
`
`$2,410
`$2,410
`$2,410
`
`$2,510
`$2,510
`$2,510
`
`Cobalt chromium technology allows for thin
`struts for excellent outcomes without
`compromising strength or radiopacity.
`
`Flexible low profile design
`
`GUIDANT MULTI-LINK MINI VISION™ OTW
`C o r o n a r y S t e n t S y s t e m
`
`Stock
`Number
`
`UPN
`Number
`
`1010152-08
`1010153-08
`1010154-08
`
`00802526331008
`00802526331060
`00802526331121
`
`1010152-12
`1010153-12
`1010154-12
`
`00802526331015
`00802526331077
`00802526331138
`
`1010152-15
`1010153-15
`1010154-15
`
`1010152-18
`1010153-18
`1010154-18
`
`1010152-23
`1010153-23
`1010154-23
`
`00802526331022
`00802526331084
`00802526331145
`
`00802526331039
`00802526331091
`00802526331152
`
`00802526331046
`00802526331107
`00802526331169
`
`Stent Sizes
`Available
`(mm)
`
`Stent Length
`(mm)
`
`Stent
`Nominal
`Pressure
`(atm)
`
`Rated Burst
`Pressure
`(atm)
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`8
`8
`8
`
`12
`12
`12
`
`15
`15
`15
`
`18
`18
`18
`
`23
`23
`23
`
`8
`9
`9
`
`8
`9
`9
`
`8
`9
`9
`
`8
`9
`9
`
`8
`9
`9
`
`16
`16
`16
`
`16
`16
`16
`
`16
`16
`16
`
`16
`16
`16
`
`16
`16
`16
`
`16
`8
`28
`2.00
`00802526331053
`1010152-28
`16
`9
`28
`2.25
`00802526331114
`1010153-28
`16
`9
`28
`2.50
`00802526331176
`1010154-28
`Minimum I.D. of Guiding Catheter = .056" Maximum Guide Wire = .014"
`
`
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
`
`
`Page 7
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`MULTI-LINK MINI VISION™ Coronary Stent System
`
`INDICATIONS
`The Guidant MULTI-LINK MINI VISION™ RX and Guidant MULTI-LINK MINI VISION™ OTW Coronary Stent Systems are
`indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed
`interventional therapy of de novoand restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel
`diameters from 2.0 to 2.5 mm.
`
`CONTRAINDICATIONS
`The Guidant MULTI-LINK MINI VISION™ Coronary Stent Systems are contraindicated for use in:
`• Patients in whom anti-platelet and / or anti-coagulant therapy is contraindicated.
`• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
`
`WARNINGS AND PRECAUTIONS
`Also see Individualization of Treatment in the IFU.
`
`WARNINGS
`Long term outcome for this permanent implant is unknown at present.
`• Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis,
`vascular complications and / or bleeding events.
`• Persons allergic to L-605 CoCr alloy may suffer an allergic reaction to this implant.
`• Implantation of the stent should be performed only by physicians who have received appropriate training.
`• Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be
`readily performed.
`• Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome
`following repeat dilatation of endothelialized stents is unknown at present.
`• When multiple stents are required, stent materials should be of similar composition. A combination of 316L stainless steel
`and L-605 CoCr alloy is acceptable should this be required.
`
`Stent Handling - Precautions
`• For single use only. Do not resterilize or reuse. Note the product "Use By" date.
`• Do not remove the stent from its Delivery System as removal may damage the stent and / or lead to stent embolization.
`Stent system is intended to perform together as a system.
`• Delivery System should not be used in conjunction with other stents.
`• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during
`catheter removal from packaging, placement over guide wire and advancement through rotating hemostatic valve adapter
`and guiding catheter hub.
`• Do not manipulate (e.g., "roll") the stent with your fingers, as this action may loosen the stent from the delivery balloon.
`• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon, as this
`may cause uneven expansion and difficulty in deployment of the stent.
`
`Stent Placement - Precautions
`• Do not prepare or pre-inflate Delivery System prior to stent deployment other than as directed. Use balloon purging
`technique described in Delivery System Preparation.
`• Implanting a stent may lead to dissection of the vessel distal and / or proximal to the stent and may cause acute closure of
`the vessel requiring additional intervention (CABG, further dilatation, placement of additional stents, or other).
`• When treating multiple lesions, stent the distal lesion prior to stenting the proximal lesion. Stenting in this order obviates
`the need to cross the proximal stent in placement of the distal stent, and reduces the chance of dislodging the proximal
`stent.
`• Do not expand the stent if it is not properly positioned in the vessel. (See Stent / System Removal – Precautions.)
`• Placement of a stent has the potential to compromise side branch patency.
`• Do not exceed the Rated Burst Pressure as indicated on the product label. Monitor balloon pressures during inflation.
`Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and
`dissection.
`• An unexpanded stent may be retracted into the guiding catheter one time only. Subsequent movement in and out through
`the distal end of the guiding catheter should not be performed as the stent may be damaged when retracting the
`undeployed stent back into the guiding catheter. Should any resistance be felt at any time during withdrawal of the
`Coronary Stent System, the entire system should be removed as a single unit.
`• Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the coronary
`vasculature and / or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm.
`
`Stent / System Removal - Precautions
`Should any resistance be felt at any time during either lesion access or removal of the Delivery System post-stent
`implantation, the entire system should be removed as a single unit.
`
`When removing the Delivery System as a single unit:
`• DO NOT retract the Delivery System into the guiding catheter.
`• Position the proximal balloon marker just distal to the tip of the guiding catheter.
`• Advance the guide wire into the coronary anatomy as far distally as safely possible.
`• Tighten the rotating hemostatic valve to secure the Delivery System to the guiding catheter; then remove the guiding
`catheter and Delivery System as a single unit.
`Failure to follow these steps and / or applying excessive force to the Delivery System can potentially result in loss or damage
`to the stent and / or Delivery System components.
`
`If it is necessary to retain guide wire position for subsequent artery / lesion access, leave the guide wire in place and remove
`all other system components.
`
`Post Implant - Precautions
`When crossing a newly deployed stent with a guide wire, balloon or Delivery System, exercise care to avoid disrupting the
`stent geometry.
`
`MRI (Magnetic Resonance Imaging) Statement
`The Guidant MULTI-LINK MINI VISION™ stent has been shown in non-clinical testing to be MRI safe immediately following
`implantation. MRI test conditions used to evaluate this stent were: for magnetic field interactions, a static magnetic field
`strength of 3 tesla with a maximum spatial gradient magnetic field of 3.3 tesla/meter; for MRI-related heating, a maximum
`whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. While a single stent
`produced a temperature rise of less than 0.6°C and should not migrate under these conditions, the response of overlapping
`stents or stents with fractured struts is unknown. Non-clinical testing has not been performed to rule out the possibility of
`stent migration at field strengths higher than 3 tesla. MR image quality may be compromised if the area of interest is in the
`exact same area or relatively close to the position of the stent.
`
`ADVERSE EVENTS
`Potential Adverse Events
`Adverse events may be associated with the use of a coronary stent in native coronary arteries:
`• Acute myocardial infarction
`• Allergic reaction to contrast
`• Arterial perforation
`• Arterial rupture
`• Arteriovenous fistula
`• Cardiac arrhythmias
`• Bleeding complications (including transfusions)
`• Coronary spasm
`• Death
`• Dissection of the coronary artery
`• Drug reaction to anti-platelet agent
`• Emergency or non-emergent coronary artery bypass graft surgery
`• Entry site complications
`• Hypotension / hypertension
`• Infection
`• Injury to the coronary artery
`• Ischemia
`• Pseudoaneurysm
`• Restenosis of the stented segment
`• Stent embolization
`• Stent thrombosis / emboli
`• Stroke / cerebrovascular accident
`• Total occlusion of the coronary artery
`• Unstable angina pectoris
`• Vascular complications
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
`
`
`Page 8
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`C O R O N A R Y S T E N T
`
`S Y S T E M S
`
`.014" maximum
`guide wire
`diameter
`
`List
`Price
`($)
`
`$2,150
`$2,150
`$2,150
`
`$2,200
`$2,200
`$2,200
`
`$2,225
`$2,225
`$2,225
`
`$2,260
`$2,260
`$2,260
`
`$2,410
`$2,410
`$2,410
`
`$2,510
`$2,510
`$2,510
`
`Cobalt chromium technology allows for thin
`struts for excellent outcomes without
`compromising strength or radiopacity.
`
`Flexible low profile design
`
`GUIDANT MULTI-LINK MINI VISION™ RX
`C o r o n a r y S t e n t S y s t e m
`
`Stock
`Number
`
`1007821-08
`1007822-08
`1007823-08
`
`1007821-12
`1007822-12
`1007823-12
`
`1007821-15
`1007822-15
`1007823-15
`
`1007821-18
`1007822-18
`1007823-18
`
`1007821-23
`1007822-23
`1007823-23
`
`UPN
`Number
`
`00802526365553
`00802526365614
`00802526365676
`
`00802526365560
`00802526365621
`00802526365683
`
`00802526365577
`00802526365638
`00802526365690
`
`00802526365584
`00802526365645
`00802526365706
`
`00802526365591
`00802526365652
`00802526365713
`
`Stent Sizes
`Available
`(mm)
`
`Stent Length
`(mm)
`
`Stent
`Nominal
`Pressure
`(atm)
`
`Rated Burst
`Pressure
`(atm)
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`2.00
`2.25
`2.50
`
`8
`8
`8
`
`12
`12
`12
`
`15
`15
`15
`
`18
`18
`18
`
`23
`23
`23
`
`8
`9
`9
`
`8
`9
`9
`
`8
`9
`9
`
`8
`9
`9
`
`8
`9
`9
`
`16
`16
`16
`
`16
`16
`16
`
`16
`16
`16
`
`16
`16
`16
`
`16
`16
`16
`
`16
`8
`28
`2.00
`00802526365607
`1007821-28
`16
`9
`28
`2.25
`00802526365669
`1007822-28
`16
`9
`28
`2.50
`00802526365720
`1007823-28
`Minimum I.D. of Guiding Catheter = .056" Maximum Guide Wire = .014"
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
`
`
`Page 9
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`MULTI-LINK MINI VISION™ Coronary Stent System
`
`INDICATIONS
`The Guidant MULTI-LINK MINI VISION™ RX and Guidant MULTI-LINK MINI VISION™ OTW Coronary Stent Systems are
`indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed
`interventional therapy of de novoand restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel
`diameters from 2.0 to 2.5 mm.
`
`CONTRAINDICATIONS
`The Guidant MULTI-LINK MINI VISION™ Coronary Stent Systems are contraindicated for use in:
`• Patients in whom anti-platelet and / or anti-coagulant therapy is contraindicated.
`• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
`
`WARNINGS AND PRECAUTIONS
`Also see Individualization of Treatment in the IFU.
`
`WARNINGS
`Long term outcome for this permanent implant is unknown at present.
`• Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis,
`vascular complications and / or bleeding events.
`• Persons allergic to L-605 CoCr alloy may suffer an allergic reaction to this implant.
`• Implantation of the stent should be performed only by physicians who have received appropriate training.
`• Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be
`readily performed.
`• Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome
`following repeat dilatation of endothelialized stents is unknown at present.
`• When multiple stents are required, stent materials should be of similar composition. A combination of 316L stainless steel
`and L-605 CoCr alloy is acceptable should this be required.
`
`Stent Handling - Precautions
`• For single use only. Do not resterilize or reuse. Note the product "Use By" date.
`• Do not remove the stent from its Delivery System as removal may damage the stent and / or lead to stent embolization.
`Stent system is intended to perform together as a system.
`• Delivery System should not be used in conjunction with other stents.
`• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during
`catheter removal from packaging, placement over guide wire and advancement through rotating hemostatic valve adapter
`and guiding catheter hub.
`• Do not manipulate (e.g., "roll") the stent with your fingers, as this action may loosen the stent from the delivery balloon.
`• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon, as this
`may cause uneven expansion and difficulty in deployment of the stent.
`
`Stent Placement - Precautions
`• Do not prepare or pre-inflate Delivery System prior to stent deployment other than as directed. Use balloon purging
`technique described in Delivery System Preparation.
`• Implanting a stent may lead to dissection of the vessel distal and / or proximal to the stent and may cause acute closure of
`the vessel requiring additional intervention (CABG, further dilatation, placement of additional stents, or other).
`• When treating multiple lesions, stent the distal lesion prior to stenting the proximal lesion. Stenting in this order obviates
`the need to cross the proximal stent in placement of the distal stent, and reduces the chance of dislodging the proximal
`stent.
`• Do not expand the stent if it is not properly positioned in the vessel. (See Stent / System Removal – Precautions.)
`• Placement of a stent has the potential to compromise side branch patency.
`• Do not exceed the Rated Burst Pressure as indicated on the product label. Monitor balloon pressures during inflation.
`Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and
`dissection.
`• An unexpanded stent may be retracted into the guiding catheter one time only. Subsequent movement in and out through
`the distal end of the guiding catheter should not be performed as the stent may be damaged when retracting the
`undeployed stent back into the guiding catheter. Should any resistance be felt at any time during withdrawal of the
`Coronary Stent System, the entire system should be removed as a single unit.
`• Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the coronary
`vasculature and / or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm.
`
`Stent / System Removal - Precautions
`Should any resistance be felt at any time during either lesion access or removal of the Delivery System post-stent
`implantation, the entire system should be removed as a single unit.
`
`When removing the Delivery System as a single unit:
`• DO NOT retract the Delivery System into the guiding catheter.
`• Position the proximal balloon marker just distal to the tip of the guiding catheter.
`• Advance the guide wire into the coronary anatomy as far distally as safely possible.
`• Tighten the rotating hemostatic valve to secure the Delivery System to the guiding catheter; then remove the guiding
`catheter and Delivery System as a single unit.
`Failure to follow these steps and / or applying excessive force to the Delivery System can potentially result in loss or damage
`to the stent and / or Delivery System components.
`
`If it is necessary to retain guide wire position for subsequent artery / lesion access, leave the guide wire in place and remove
`all other system components.
`
`Post Implant - Precautions
`When crossing a newly deployed stent with a guide wire, balloon or Delivery System, exercise care to avoid disrupting the
`stent geometry.
`
`MRI (Magnetic Resonance Imaging) Statement
`The Guidant MULTI-LINK MINI VISION™ stent has been shown in non-clinical testing to be MRI safe immediately following
`implantation. MRI test conditions used to evaluate this stent were: for magnetic field interactions, a static magnetic field
`strength of 3 tesla with a maximum spatial gradient magnetic field of 3.3 tesla/meter; for MRI-related heating, a maximum
`whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. While a single stent
`produced a temperature rise of less than 0.6°C and should not migrate under these conditions, the response of overlapping
`stents or stents with fractured struts is unknown. Non-clinical testing has not been performed to rule out the possibility of
`stent migration at field strengths higher than 3 tesla. MR image quality may be compromised if the area of interest is in the
`exact same area or relatively close to the position of the stent.
`
`ADVERSE EVENTS
`Potential Adverse Events
`Adverse events may be associated with the use of a coronary stent in native coronary arteries:
`• Acute myocardial infarction
`• Allergic reaction to contrast
`• Arterial perforation
`• Arterial rupture
`• Arteriovenous fistula
`• Cardiac arrhythmias
`• Bleeding complications (including transfusions)
`• Coronary spasm
`• Death
`• Dissection of the coronary artery
`• Drug reaction to anti-platelet agent
`• Emergency or non-emergent coronary artery bypass graft surgery
`• Entry site complications
`• Hypotension / hypertension
`• Infection
`• Injury to the coronary artery
`• Ischemia
`• Pseudoaneurysm
`• Restenosis of the stented segment
`• Stent embolization
`• Stent thrombosis / emboli
`• Stroke / cerebrovascular accident
`• Total occlusion of the coronary artery
`• Unstable angina pectoris
`• Vascular complications
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
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`Page 10
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`Teleflex Ex. 2211
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`

`

`Cobalt chromium technology allows for thin
`struts for excellent clinical outcomes without
`compromising strength or radiopacity.
`
`Flexible low profile design
`
`.014" maximum
`guide wire
`diameter
`
`C O R O N A R Y S T E N T
`
`S Y S T E M S
`
`GUIDANT MULTI-LINK VISION® OTW
`C o r o n a r y S t e n t S y s t e m
`
`Stock
`Number
`
`1010142-08
`1010143-08
`1010144-08
`1010145-08
`
`1010142-12
`1010143-12
`1010144-12
`1010145-12
`
`1010142-15
`1010143-15
`1010144-15
`1010145-15
`
`1010142-18
`1010143-18
`1010144-18
`1010145-18
`
`1010142-23
`1010143-23
`1010144-23
`1010145-23
`
`UPN
`Number
`
`00802526328985
`00802526329043
`00802526329128
`00802526329203
`
`00802526328992
`00802526329050
`00802526329135
`00802526329210
`
`00802526329005
`00802526329067
`00802526329142
`00802526329227
`
`00802526329012
`00802526329074
`00802526329159
`00802526329234
`
`00802526329029
`00802526329081
`00802526329166
`00802526329241
`
`Stent Sizes
`Available
`(mm)
`
`Stent Length
`(mm)
`
`Stent
`Nominal
`Pressure
`(atm)
`
`Rated Burst
`Pressure
`(atm)
`
`2.75
`3.00
`3.50
`4.00
`
`2.75
`3.00
`3.50
`4.00
`
`2.75
`3.00
`3.50
`4.00
`
`2.75
`3.00
`3.50
`4.00
`
`2.75
`3.00
`3.50
`4.00
`
`8
`8
`8
`8
`
`12
`12
`12
`12
`
`15
`15
`15
`15
`
`18
`18
`18
`18
`
`23
`23
`23
`23
`
`9
`9
`9
`9
`
`9
`9
`9
`9
`
`9
`9
`9
`9
`
`9
`9
`9
`9
`
`9
`9
`9
`9
`
`16
`16
`16
`16
`
`16
`16
`16
`16
`
`16
`16
`16
`16
`
`16
`16
`16
`16
`
`16
`16
`16
`16
`
`16
`9
`28
`2.75
`00802526329036
`1010142-28
`16
`9
`28
`3.00
`00802526329098
`1010143-28
`16
`9
`28
`3.50
`00802526329173
`1010144-28
`16
`9
`28
`4.00
`00802526329258
`1010145-28
`Minimum I.D. of Guiding Catheter = .056" Maximum Guide Wire = .014"
`
`List
`Price
`($)
`
`$2,150
`$2,150
`$2,150
`$2,150
`
`$2,200
`$2,200
`$2,200
`$2,200
`
`$2,225
`$2,225
`$2,225
`$2,225
`
`$2,260
`$2,260
`$2,260
`$2,260
`
`$2,410
`$2,410
`$2,410
`$2,410
`
`$2,510
`$2,510
`$2,510
`$2,510
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
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`
`Page 11
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`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`MULTI-LINK VISION® Coronary Stent System
`
`INDICATIONS:
`The Guidant MULTI-LINK VISION® RX and Guidant MULTI-LINK VISION® OTW Coronary Stent Systems are indicated for
`improving coronary luminal diameter in the following (see Individualization of Treatment):
`• Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions
`(length ≤ 25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.
`• Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length ≤ 25 mm) with
`reference vessel diameters ranging from 3.0 mm to 4.0 mm.
`• Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or
`angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length
`≤ 25 mm with a reference vessel diameter of 3.0 mm to 4.0 mm.
`Outcome (beyond 9 months) for this permanent implant is unknown at present.
`
`CONTRAINDICATIONS:
`The Guidant MULTI-LINK VISION® RX and Guidant MULTI-LINK VISION® OTW Coronary Stent Systems are contraindicated
`for use in:
`• Patients in whom anti-platelet and / or anti-coagulant therapy is contraindicated.
`• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
`
`WARNINGS AND PRECAUTIONS (see Individualization of Treatment):
`
`WARNINGS
`• Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute
`thrombosis, vascular complications and / or bleeding events.
`• Persons allergic to L-605 cobalt chromium alloy may suffer an allergic reaction to this implant.
`•
`Implantation of the stent should be performed only by physicians who have received appropriate training.
`• Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be
`readily performed.
`• Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome
`following repeat dilatation of endothelialized stents is unknown at present.
`• When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different
`metals in contact with each other may increase the potential for corrosion. The risk of in vivocorrosion does not appear
`to increase based on in vitro corrosion tests using an L-605 CoCr alloy stent (Guidant MULTI-LINK VISION® Coronary
`Stent) in combination with a 316L stainless steel alloy stent (Guidant MULTI-LINK TETRA™ Coronary Stent).
`
`Stent Handling - Precautions
`• For single use only. Do not resterilize or reuse. Note the product "Use By" date.
`• Do not remove stent from its Delivery System as removal may damage the stent and / or lead to stent embolization.
`Stent system is intended to perform as a system.
`• Delivery System should not be used in conjunction with other stents.
`• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during
`catheter removal from packaging, placement over guide wire and advancement through rotating hemostatic valve
`adapter and guiding catheter hub.
`• Do not manipulate (e.g.,"roll") the stent with your fingers, as this action may loosen the stent from the delivery balloon.
`• Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon as this
`may cause uneven expansion and difficulty in deployment of the stent.
`
`•
`
`Stent Placement - Precautions
`• Do not prepare or pre-inflate Delivery System prior to stent deployment other than as directed. Use balloon purging
`technique described in Delivery System Preparation (9.3.2).
`Implanting a stent may lead to dissection of the vessel distal and / or proximal to the stent and may cause acute closure
`of the vessel requiring additional intervention (CABG, further dilatation, placement of additional stents, or other).
`• When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion.
`Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the
`chances for dislodging the proximal stent.
`
`• Do not expand the stent if it is not properly positioned in the vessel. (See Stent / System Removal - Precautions (5.3)
`• Placement of a stent has the potential to compromise side branch patency.
`• Do not exceed Rated Burst Pressure (RBP) as indicated on product label. Balloon pressures should be monitored
`during inflation. Use of pressures higher than specified on product label may result in a ruptured balloon with possible
`intimal damage and dissection.
`• An unexpanded stent may be retracted into the guiding catheter one time only. Subsequent movement in and out
`through the distal end of the guiding catheter should not be performed as the stent may be damaged when retracting the
`undeployed stent back into the guiding catheter. Should any resistance be felt at any time during withdrawal of the
`Coronary Stent System, the entire system should be removed as a single unit.
`• Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the coronary
`vasculature and / or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm.
`
`Stent / System Removal - Precautions
`Should any resistance be felt at any time during either lesion access or removal of the Delivery System post-stent
`implantation, the entire system should be removed as a single unit.
`When removing the Delivery System as a single unit:
`• DO NOT retract the Delivery System into the guiding catheter.
`• Position the proximal balloon marker just distal to the tip of the guiding catheter.
`• Advance the guide wire into the coronary anatomy as far distally as safely possible.
`• Tighten the rotating hemostatic valve to secure the Delivery System to the guiding catheter; then remove the guiding
`catheter and Delivery System as a single unit.
`Failure to follow these steps and / or applying excessive force to the Delivery System can potentially result in loss or
`damage to the stent and / or Delivery System components.
`If it is necessary to retain guide wire position for subsequent artery / lesion access, leave the guide wire in place and
`remove all other system components.
`
`Post Implant - Precautions
`• Care must be exercised when crossing a newly deployed stent with a coronary guide wire, balloon or Delivery System
`to avoid disrupting the stent geometry.
`
`POTENTIAL ADVERSE EVENTS:
`Adverse events may be associated with the use of a coronary stent in native coronary arteries:
`• Acute myocardial infarction
`• Arrhythmias, including VF and VT
`• Death
`• Dissection
`• Drug reactions to anti-platelet agents / contrast medium
`• Emboli, distal (air, tissue or thrombotic emboli)
`• Emergent Coronary Artery Bypass Surgery
`• Hemorrhage, requiring transfusion
`• Hypotension / Hypertension
`•
`Infection and / or pain at insertion site
`•
`Ischemia, Myocardial
`• Perforation
`• Pseudoaneurysm, Femoral
`• Restenosis of stented segment
`• Spasm
`• Stent embolization
`• Stent thrombosis / occlusion
`• Stroke / cerebrovascular accident
`• Total occlusion of coronary artery
`
`C U S T O M E R S E R V I C E 8 0 0 2 2 7 - 9 9 0 2
`
`
`Page 12
`
`Teleflex Ex. 2211
`Medtronic v. Teleflex
`
`

`

`C O R O N A R Y S T E N T
`
`S Y S T E M S
`
`.014" maximum
`guide wire
`diameter
`
`List
`Price
`($)
`
`$2,150
`$2,150
`$2,150
`$2,150
`
`$2,200
`$2,200
`$2,200
`$2,200
`
`$2,225
`$2,225
`$2,225
`$2,225
`
`$2,260
`$2,260
`$2,260
`$2,260
`
`$2,410
`$2,410
`$2,410
`$2,410
`
`$2,510
`$2,510
`$2,510
`$2,510
`
`Cobalt chromium technology allows for thin
`struts for excellent c