Important Safety Information for Patients

	ELCA® and ELCA® X-80
	QuickCat™
	Spectranetics Support Catherter Lines
	Turbo-Booster®, Turbo-Elite®, and Turbo-Tandem®
	SLS® II, LLD®, and VisiSheath®
	TorqMax®

ELCA® and ELCA® X-80

The Excimer Laser Coronary Atherectomy Catheters (ELCA) are used in conjunction with the Spectranetics CVX-300® Excimer Laser System and are intended for use in patients with a variety of blockages in single or multivessel coronary artery disease. ELCA is usually used in conjunction with other therapies, such as balloon angioplasty or stenting. The use of ELCA may be unsafe in some patients or in treating certain types of blockages. The ELCA X-80 catheter should not be used in patients with weakened heart muscles (ejection fraction <30%) or in cases of acute heart attacks. Rarely a patient undergoing ELCA may require urgent surgical treatment for a complication; therefore, patients who are not candidates for coronary bypass graft surgery should not undergo treatment with ELCA. Ask your doctor if you are a candidate for ELCA.

Potential adverse events associated with procedures used to treat coronary artery disease may include: a tear, rupture, damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot, or obstruction of the artery by plaque debris. Other complications may occur.

Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding; vascular damage, loss of blood flow or other complications; and irregular heartbeat, heart attack or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

QuickCat™

The Spectranetics QuickCat™ Extraction Catheter is indicated for removal of fresh, soft emboli and thrombi from arterial blood vessels.

Potential adverse events associated with the use of the QuickCat catheter include: a sudden, temporary or ongoing re-closure of the treated blood vessels, blood clot or obstruction of the artery by plaque debris; a tear, rupture or damage to the artery, vein or bypass graft; minor bleeding or bruising at the entry site. Other complications may occur.

Rare but serious potential adverse events associated with the use of some aspiration catheters that have been reported include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flow, inability to restore blood flow or other complications; drug reactions for medications used during the procedure; decrease or loss of kidney function due to contrast exposure; infection, stroke, pulmonary embolism, heart attack or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

Spectranetics Support Catheter Lines

The Spectranetics Support Catheters, which include the Quick-Cross®, Quick-Cross® Extreme®, and Quick-Cross® Select, are intravascular catheters of varying design. The Quick-Cross, Quick-Cross Extreme and Quick-Cross Select catheters are intended to support a guidewire during access to the blood vessels and allow for delivery of saline solutions or contrast agents.

Potential adverse events associated with vascular procedures using these devices may include: a tear, rupture or damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris; minor bleeding or bruising at the entry site. Other complications may occur.

Rare but serious potential adverse events include: infection, chest pain, low or high blood pressure, irregular heartbeat, heart attack or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

Turbo-Booster®, Turbo-Elite®, and Turbo-Tandem®

The Turbo-Booster® Guiding Catheter, Turbo Elite® Laser Catheter, and Turbo-Tandem® Laser Catheter are intended for the treatment of blockages associated with peripheral arterial disease (PAD) in the legs.

Potential adverse events associated with procedures used to treat PAD may include: a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris; a tear, rupture or damage to the artery (or nearby vein or nerve); minor bleeding or bruising at the entry site. Other complications may occur.

Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flow or other complications; decrease or loss of kidney function due to contrast exposure; the need for amputation due to inability to restore blood flow; and infection, stroke, irregular heartbeat, heart attack or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

SLS® II, LLD®, and VisiSheath®

The Spectranetics Laser Sheath (SLS II) is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the SLS II Laser Sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the SLS II Laser Sheath.

The Spectranetics Lead Locking Device (LLD) is intended for use in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the LLD may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Ask your doctor if you are a candidate for lead extraction with the Spectranetics LLD.

The Spectranetics VisiSheath Dilator Sheath is intended for use in patients requiring pacemaker or defibrillator lead extraction or removal of other catheters or foreign objects that have become attached to the wall of the blood vessel. The device is also intended to help place new intravascular catheters. Rarely a patient undergoing lead or catheter extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead or catheter extraction in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the VisiSheath.

Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung. Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

TorqMax®

The TorqMax Sheath Grip Accessory is intended for use in providing ergonomic grip on outer support sheaths, dilator sheaths and Spectranetics laser sheaths. There are no known potential adverse events associated specifically with the TorqMax.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

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