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Home Healthcare Professionals Products Cardiovascular Drug-Coated Balloons
IN.PACT Admiral & IN.PACT 018 Indications, Safety, & Warnings






INDICATIONS, SAFETY, AND WARNINGS IN.PACT™ ADMIRAL™ AND IN.PACT™ 018 DRUG-COATED
BALLOONS


QUICK LINKS TO SECTIONS

 * IN.PACT Admiral and IN.PACT 018 DCB
 * IN.PACT Admiral DCB
 * IN.PACT 018 DCB
   

Note: Safety information provided is for the United States. Please refer to your
region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult with your physician. A
prescription is required. For more information, please call Medtronic at
877-526-7890. Prior to use, refer to the Instructions for Use supplied with
these devices for indications, contraindications, side effects, suggested
procedure, warnings, and precautions. This content is available electronically
at manuals.medtronic.com(opens new window).

--------------------------------------------------------------------------------


IN.PACT ADMIRAL AND IN.PACT 018 DCB


INSTRUCTIONS FOR USE

The IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter and IN.PACT 018
Paclitaxel-coated PTA Balloon Catheter are indicated for percutaneous
transluminal angioplasty, after appropriate vessel preparation, of de novo,
restenotic, or in-stent restenotic lesions with lengths up to 360 mm in
superficial femoral or popliteal arteries with reference vessel diameters of 4–7
mm.


CONTRAINDICATIONS

The IN.PACT Admiral DCB and IN.PACT 018 DCB are contraindicated for use in:

 * Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries.
 * Patients who cannot receive recommended antiplatelet and/or anticoagulant
   therapy.
 * Patients judged to have a lesion that prevents complete inflation of an
   angioplasty balloon or proper placement of the delivery system.
 * Patients with known allergies or sensitivities to paclitaxel.
 * Women who are breastfeeding, pregnant or are intending to become pregnant, or
   men intending to father children. It is unknown whether paclitaxel will be
   excreted in human milk and whether there is a potential for adverse reaction
   in nursing infants from paclitaxel exposure.


WARNINGS

 * A signal for increased risk of late mortality has been identified following
   the use of paclitaxel-coated balloons and paclitaxel-eluting stents for
   femoropopliteal arterial disease beginning approximately 2–3 years
   post-treatment compared with the use of non-drug coated devices. There is
   uncertainty regarding the magnitude and mechanism for the increased late
   mortality risk, including the impact of repeat paclitaxel-coated device
   exposure. Physicians should discuss this late mortality signal and the
   benefits and risks of available treatment options with their patients.
 * Use the product prior to the Use-by Date specified on the package.
 * Contents are supplied sterile. Do not use the product if the inner packaging
   is damaged or opened.
 * Do not use air or any gaseous medium to inflate the balloon. Use only the
   recommended inflation medium (equal parts contrast medium and saline
   solution).
 * Do not move the guidewire during inflation of the IN.PACT Admiral DCB or
   IN.PACT 018 DCB.
 * Do not exceed the rated burst pressure (RBP). The RBP is based on the results
   of in vitro testing. Use of pressures higher than RBP may result in a
   ruptured balloon with possible intimal damage and dissection. [IN.PACT
   Admiral DCB: The RBP is 14 atm (1419 kPa) for all balloons except the 200 and
   250 mm balloons. For the 200 and 250 mm balloons the RBP is 11 atm (1115 kPa)
   – IN.PACT 018 DCB: The RBP is 10 atm (1013 kPa) for all balloons.]
 * The safety and effectiveness of using multiple IN.PACT Admiral DCB, or
   multiple IN.PACT 018 DCB, with a total drug dosage exceeding 34,854 μg of
   paclitaxel in a patient has not been clinically evaluated.


PRECAUTIONS

 * The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire
   compatible), as established in the clinical studies that were performed
   primarily via femoral access, can be considered supportive for the IN.PACT
   018 DCB. Vessel preparation using only pre-dilatation was studied in the
   IN.PACT Admiral DCB clinical studies. Other methods of vessel preparation,
   such as atherectomy, have not been studied clinically. The IN.PACT 018 DCB
   has not been evaluated in a clinical study.
 * The IN.PACT Admiral DCB and IN.PACT 018 DCB should only be used by physicians
   trained in percutaneous transluminal angioplasty (PTA).
 * The IN.PACT Admiral DCB and IN.PACT 018 DCB are designed for single patient
   use only. Do not reuse, reprocess, or resterilize this product. Reuse,
   reprocessing, or resterilization may compromise the structural integrity of
   the device and/or create a risk of contamination of the device, which could
   result in patient injury, illness, or death.
 * Assess risks and benefits before treating patients with a history of severe
   reaction to contrast agents.
 * The safety and effectiveness of the IN.PACT Admiral DCB or IN.PACT 018 DCB
   used in conjunction with other drug-eluting stents or drug-coated balloons in
   the same procedure or following treatment failure has not been evaluated.
 * The extent of the patient’s exposure to the drug coating is directly related
   to the number of balloons used. Refer to the Instructions for Use (IFU) for
   details regarding the use of multiple balloons and paclitaxel content.
 * The use of the IN.PACT Admiral DCB and IN.PACT 018 DCB carries the risks
   associated with percutaneous transluminal angioplasty, including thrombosis,
   vascular complications, and/or bleeding events.
 * The IN.PACT Admiral DCB and IN.PACT 018 DCB are not intended for the
   expansion or delivery of a stent.


POTENTIAL ADVERSE EFFECTS

The potential adverse effects (e.g., complications) associated with the use of
the device are: abrupt vessel closure; access site pain; allergic reaction to
contrast medium, antiplatelet therapy, or catheter system components (materials,
drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm;
arterial thrombosis; arteriovenous (AV) fistula; death; dissection;
embolization; fever; hematoma; hemorrhage; hypotension/hypertension;
inflammation; ischemia or infarction of tissue/ organ; local infection at access
site; local or distal embolic events; perforation or rupture of the artery;
pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated
artery; sepsis or systemic infection; shock; stroke; systemic embolization;
vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are
not limited to: balloon rupture; detachment of a component of the balloon and/or
catheter system; failure of the balloon to perform as intended; failure to cross
the lesion. Although systemic effects are not anticipated, potential adverse
events that may be unique to the paclitaxel drug coating include, but are not
limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal
symptoms; hematologic dyscrasia (including leucopenia, neutropenia,
thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall,
including inflammation, cellular damage, or necrosis; myalgia/arthralgia;
myelosuppression; peripheral neuropathy. Refer to the Physicians' Desk
Reference for more information on the potential adverse effects observed with
paclitaxel. There may be other potential adverse effects that are unforeseen at
this time. 

Please reference appropriate product Instructions for Use for a detailed list of
indications, warnings, precautions, and potential adverse effects. This content
is available electronically at manuals.medtronic.com(opens new window).

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
physician.

FTSOP113326-32 Rev. 1H

--------------------------------------------------------------------------------


IN.PACT ADMIRAL DCB


INDICATIONS FOR USE


The IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter is indicated for
percutaneous transluminal angioplasty, after appropriate vessel preparation, of
de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in
superficial femoral or popliteal arteries with reference vessel diameters of 4–7
mm.


CONTRAINDICATIONS

The IN.PACT Admiral DCB is contraindicated for use in:

 * Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
 * Patients who cannot receive recommended antiplatelet and/or anticoagulant
   therapy
 * Patients judged to have a lesion that prevents complete inflation of an
   angioplasty balloon or proper placement of the delivery system
 * Patients with known allergies or sensitivities to paclitaxel
 * Women who are breastfeeding, pregnant, or are intending to become pregnant or
   men intending to father children. It is unknown whether paclitaxel will be
   excreted in human milk and whether there is a potential for adverse reaction
   in nursing infants from paclitaxel exposure.


WARNINGS

 * A signal for increased risk of late mortality has been identified following
   the use of paclitaxel-coated balloons and paclitaxel-eluting stents for
   femoropopliteal arterial disease beginning approximately 2–3 years
   post-treatment compared with the use of non-drug coated devices. There is
   uncertainty regarding the magnitude and mechanism for the increased late
   mortality risk, including the impact of repeat paclitaxel-coated device
   exposure. Physicians should discuss this late mortality signal and the
   benefits and risks of available treatment options with their patients.
 * Use the product prior to the Use-by Date specified on the package.
 * Contents are supplied sterile. Do not use the product if the inner packaging
   is damaged or opened.
 * Do not use air or any gaseous medium to inflate the balloon. Use only the
   recommended inflation medium (equal parts contrast medium and saline
   solution).
 * Do not move the guidewire during inflation of the IN.PACT Admiral DCB.
 * Do not exceed the rated burst pressure (RBP). The RBP is 14 atm (1419 kPa)
   for all balloons except the 200 and 250 mm balloons. For the 200 and 250 mm
   balloons the RBP is 11 atm (1115 kPa). The RBP is based on the results of in
   vitro testing. Use of pressures higher than RBP may result in a ruptured
   balloon with possible intimal damage and dissection.
 * The safety and effectiveness of using multiple IN.PACT Admiral DCBs with a
   total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been
   clinically evaluated.


PRECAUTIONS

 * This product should only be used by physicians trained in percutaneous
   transluminal angioplasty (PTA).
 * This product is designed for single patient use only. Do not reuse,
   reprocess, or resterilize this product. Reuse, reprocessing, or
   resterilization may compromise the structural integrity of the device and/or
   create a risk of contamination of the device, which could result in patient
   injury, illness, or death.
 * Assess risks and benefits before treating patients with a history of severe
   reaction to contrast agents.
 * The safety and effectiveness of the IN.PACT Admiral DCB used in conjunction
   with other drug-eluting stents or drug-coated balloons in the same procedure
   or following treatment failure has not been evaluated.
 * The extent of the patient’s exposure to the drug coating is directly related
   to the number of balloons used. Refer to the Instructions for Use (IFU) for
   details regarding the use of multiple balloons and paclitaxel content.
 * The use of this product carries the risks associated with percutaneous
   transluminal angioplasty, including thrombosis, vascular complications,
   and/or bleeding events.
 * Vessel preparation using only pre-dilatation was studied in the clinical
   study. Other methods of vessel preparation, such as atherectomy, have not
   been studied clinically with IN.PACT Admiral DCB.
 * This product is not intended for the expansion or delivery of a stent.


POTENTIAL ADVERSE EFFECTS

The potential adverse effects (e.g., complications) associated with the use of
the device are: abrupt vessel closure; access site pain; allergic reaction to
contrast medium, antiplatelet therapy, or catheter system components (materials,
drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm;
arterial thrombosis; arteriovenous (AV) fistula; death; dissection;
embolization; fever; hematoma; hemorrhage; hypotension/hypertension;
inflammation; ischemia or infarction of tissue/ organ; local infection at access
site; local or distal embolic events; perforation or rupture of the artery;
pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated
artery; sepsis or systemic infection; shock; stroke; systemic embolization;
vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are
not limited to the following: balloon rupture; detachment of a component of the
balloon and/or catheter system; failure of the balloon to perform as intended;
failure to cross the lesion. Although systemic effects are not anticipated,
potential adverse events that may be unique to the paclitaxel drug coating
include, but are not limited to: allergic/immunologic reaction; alopecia;
anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia,
neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in
vessel wall, including inflammation, cellular damage, or necrosis;
myalgia/arthralgia; myelosuppression; peripheral neuropathy. Refer to
the Physicians' Desk Reference for more information on the potential adverse
effects observed with paclitaxel. There may be other potential adverse effects
that are unforeseen at this time.

Please reference appropriate product Instructions for Use for a detailed list of
indications, warnings, precautions, and potential adverse effects. This content
is available electronically at manuals.medtronic.com.(opens new window)

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
physician.

--------------------------------------------------------------------------------


IN.PACT 018 PACLITAXEL-COATED PTA BALLOON CATHETER


INDICATIONS FOR USE


The IN.PACT 018 paclitaxel-coated PTA Balloon Catheter is indicated for
percutaneous transluminal angioplasty, after appropriate vessel preparation, of
de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in
superficial femoral or popliteal arteries with reference vessel diameters of 4–7
mm.


CONTRAINDICATIONS:


The IN.PACT 018 DCB is contraindicated for use in:

 * Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
 * Patients who cannot receive recommended antiplatelet and/or anticoagulant
   therapy
 * Patients judged to have a lesion that prevents complete inflation of an
   angioplasty balloon or proper placement of the delivery system
 * Patients with known allergies or sensitivities to paclitaxel
 * Women who are breastfeeding, pregnant, or are intending to become pregnant or
   men intending to father children. It is unknown whether paclitaxel will be
   excreted in human milk and whether there is a potential for adverse reaction
   in nursing infants from paclitaxel exposure.


WARNINGS

 * A signal for increased risk of late mortality has been identified following
   the use of paclitaxel-coated balloons and paclitaxel-eluting stents for
   femoropopliteal arterial disease beginning approximately 2–3 years
   post-treatment compared with the use of non-drug coated devices. There is
   uncertainty regarding the magnitude and mechanism for the increased late
   mortality risk, including the impact of repeat paclitaxel-coated device
   exposure. Physicians should discuss this late mortality signal and the
   benefits and risks of available treatment options with their patients.
 * Use the product prior to the Use-by Date specified on the package.
 * Contents are supplied sterile. Do not use the product if the inner packaging
   is damaged or opened.
 * Do not use air or any gaseous medium to inflate the balloon. Use only the
   recommended inflation medium (equal parts contrast medium and saline
   solution).
 * Do not move the guidewire during inflation of the IN.PACT 018 DCB.
 * Do not exceed the rated burst pressure (RBP). The RBP is 10 atm (1013 kPa).
   The RBP is based on the results of in vitro testing. Use of pressures higher
   than RBP may result in a ruptured balloon with possible intimal damage and
   dissection.
 * The safety and effectiveness of using multiple IN.PACT 018 DCBs with a total
   drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been
   clinically evaluated.


PRECAUTIONS

 * The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire
   compatible), as established in the clinical studies that were performed
   primarily via femoral access, can be considered supportive for the IN.PACT
   018 DCB. Vessel preparation using only pre-dilatation was studied in the
   IN.PACT Admiral DCB clinical studies. Other methods of vessel preparation,
   such as atherectomy, have not been studied clinically. The IN.PACT 018 DCB
   has not been evaluated in a clinical study.
 * This product should only be used by physicians trained in percutaneous
   transluminal angioplasty (PTA).
 * This product is designed for single patient use only. Do not reuse,
   reprocess, or resterilize this product. Reuse, reprocessing, or
   resterilization may compromise the structural integrity of the device and/or
   create a risk of contamination of the device, which could result in patient
   injury, illness, or death.
 * Assess risks and benefits before treating patients with a history of severe
   reaction to contrast agents.
 * The safety and effectiveness of the IN.PACT 018 DCB used in conjunction with
   other drug-eluting stents or drug-coated balloons in the same procedure or
   following treatment failure has not been evaluated.
 * The extent of the patient’s exposure to the drug coating is directly related
   to the number of balloons used. Refer to the Instructions for Use (IFU) for
   details regarding the use of multiple balloons and paclitaxel content.
 * The use of this product carries the risks associated with percutaneous
   transluminal angioplasty, including thrombosis, vascular complications,
   and/or bleeding events.
 * This product is not intended for the expansion or delivery of a stent.


POTENTIAL ADVERSE EFFECTS

The potential adverse effects (e.g., complications) associated with the use of
the device are: abrupt vessel closure; access site pain; allergic reaction to
contrast medium, antiplatelet therapy, or catheter system components (materials,
drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm;
arterial thrombosis; arteriovenous (AV) fistula; death; dissection;
embolization; fever; hematoma; hemorrhage; hypotension/hypertension;
inflammation; ischemia or infarction of tissue/ organ; local infection at access
site; local or distal embolic events; perforation or rupture of the artery;
pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated
artery; sepsis or systemic infection; shock; stroke; systemic embolization;
vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are
not limited to: balloon rupture; detachment of a component of the balloon and/or
catheter system; failure of the balloon to perform as intended; failure to cross
the lesion. Although systemic effects are not anticipated, potential adverse
events that may be unique to the paclitaxel drug coating include, but are not
limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal
symptoms; hematologic dyscrasia (including leucopenia, neutropenia,
thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall,
including inflammation, cellular damage, or necrosis; myalgia/arthralgia;
myelosuppression; peripheral neuropathy. Refer to the Physicians' Desk Reference
for more information on the potential adverse effects observed with paclitaxel.
There may be other potential adverse effects that are unforeseen at this time.
Please reference appropriate product Instructions for Use for a detailed list of
indications, warnings, precautions, and potential adverse effects. This content
is available electronically at manuals.medtronic.com.(opens new window)

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
physician.


RELATED PAGES

 * IN.PACT Admiral and IN.PACT 018 drug-coated balloons
 * Clinical review of DCBs
 * Paclitaxel safety


RELATED PRODUCTS

 * Drug-coated balloons
 * Cardiovascular products


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