Indications and Warnings

Please refer to full Instructions for Use on how to use these medical devices.

Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
Reprocessing may compromise the integrity of the device and/or lead to device failure.

DELTA Series Diode Laser

WARNINGS
This product is NOT intended for use with CO2 laser systems. To clean an unenergized fiber during a procedure, gently wipe along the axis of the fiber tip with sterile water on a sterile gauze pad. Allow the fiber to cool prior to wiping with sterile water. Do not use abrasive materials or sharp objects to remove residue. No coaxial cooling is required on the bare fibers. Overheating may change the shape of the tip, power density, and therapeutic tissue effects. Do not use a damaged tip. Visually inspect the tip prior to use. Proper eye protection must be worn by all personnel and patients in the treatment area. To avoid tissue adhesions to the tip, power should be applied only briefly as the tip is lifted away from the tissue. The fiber tips can be damaged by rough handling. Do NOT subject this device to impact stress. Always inspect the tip after such incidents to ensure that no damage has occurred. The surgeon must be cautious in injecting an organ with CO2 gas or air as insufflators because in doing so, an air embolism or gas embolism may occur. When working with any laser near sensitive structures (arteries, bowel, etc.) the potential for perforation always exists. It is important that the user be aware of this possibility.

SAFETY PRECAUTIONS
The Precision 980™ Diode laser is a Class IV laser per FDA 21 CFR 1040.10 and 21 CFR 1040.11. A Class IV laser is hazardous to the eye from the direct beam and diffuse reflections. It also represents a significant skin and fire hazard. Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures in the area where the laser is being used.

NeverTouch® Procedure Kit

INDICATION FOR USE
The AngioDynamics, Inc. VenaCure EVLT™ NeverTouch® - FRS Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. The VenaCure EVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

Exclusions:
Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral artery disease as determined by an Ankle- Brachial Index <0.9.

SAFETY PRECAUTION
All persons in the treatment room must be wearing protective glasses with the proper rating for the wavelength being used.

POTENTIAL COMPLICATIONS
The potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain.

WARNINGS
Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel. Do not re-use the fibers or re-sterilize the fibers.

PRECAUTIONS
Prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending of the fiber. Do not coil the fiber tighter than a diameter of 20 cm. Clinical safety and effectiveness data is not available for other fiber tip designs and diameters. Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage.

VenaCure EVLT™ Hydrophilic-Coated Trè-Sheath™ Introducer

INDICATION FOR USE
The VenaCure® Hydrophilic-Coated Trè-Sheath® Introducer is intended for use in endovascular occlusion of the Great Saphenous Vein (GSV) in patients with superficial vein reflux and for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV). The VenaCure® Hydrophilic-Coated Trè-Sheath® Introducer is indicated for use with 810 nm and 980 nm Diode Lasers.

CAUTIONS
For single use only. Do not reuse or resterilize. This device is sterilized by ethylene oxide. Physician should be familiar with insertion techniques of introducers using a guide wire (Seldinger / Modified Seldinger). Percutaneous introducer sheaths should not remain indwelling without internal support of the sheath wall. Care should be exercised during insertion, manipulation and withdrawal of the catheter or dilator through the hemostasis valve. The integrity of the hemostasis valve may be compromised with the use of excessive force or rapid withdrawal. If resistance is encountered: DO NOT FORCE. Remove the catheter or dilator and introducer as a unit. If repositioning of the sheath is necessary, ensure that internal support is provided by a vessel dilator and guidewire prior to insertion to avoid twisting the sheath. Upon withdrawal of a device, the side port should be aspirated in order to remove any clotted material that may have accumulated. This should be accomplished before the insertion of another medical device.

WARNINGS
Care should be exercised during insertion, use or removal of the device to prevent aspiration of air into the vasculature. Rapid withdrawal of the catheter or dilator through the hemostasis valve may cause misalignment of the valve gasket assembly, causing bleedback through the valve. In this scenario, the slow reinsertion of a vessel dilator tip or catheter should realign the valve stopping bleedback. Inspect the packaging and product for damage prior to use. Do not use if the package is damaged as sterility may be compromised. Tighten all connections prior to use without overtightening. Over tightening can cause damage to the components. Periodically check all connections for tightness. Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel. Do not place emitting section of the laser fiber in contact with the vessel wall during operation, since it may cause perforations to the vessel wall.

PRECAUTIONS
Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage. The sheath size must be compatible with the laser fiber.

Spotlight OPS

INDICATIONS
The Laser and Procedure Kit are intended for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous vein, and with veins in the lower limbs with superficial reflux. The D15 Plus, D30 Plus, DELTA-15 and DELTA-30 lasers and Kits are indicated for treatment of incompetent refluxing veins in the superficial venous system.

CONTRAINDICATIONS
Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

COMPLICATIONS
Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia, skin burns, and thrombophlebitis.

WARNINGS
Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel.

PRECAUTION
Prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending of the fiber. Do not coil the fiber tighter than a radius of 60 mm. The positions of the sitemarks on the VenaCure EVLT fiber have been matched to the introducer sheath provide in the VenaCure EVLT procedure kit. Alternative sheaths must not be substituted. Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage. Do not coil the sheath tighter than a radius of 60 mm. The entry needle provided with this kit is matched to the size of the guidewire and should not be substituted. Do not tighten the compression clamp on sheath until fiber is in position.

NOTE: Patients on anticoagulant therapy are still eligible for treatment. Most physicians will only treat patients with an I.N.R. (Internal Normalized Ratio) at the lower therapeutic limits. It is sometimes helpful to nick the skin with a scalpel at the puncture site either to aid insertion of the needle, or after guidewire insertion.

The VenaCure EVLT™ system can be performed under local anesthesia in the physician’s office or as an outpatient treatment. The VenaCure EVLT™ system must only be performed by a qualified physician who has received specialized training in the techniques described.

Perforator Vein Ablation Kit (PVAK)

INDICATIONS
The D15 Plus, D30 Plus, DELTA-15 and DELTA-30 lasers and VenaCure EVLT procedure kits are indicated for treatment of incompetent refluxing veins in the superficial venous system. Choosing when to treat incompetent perforators depends upon the physician’s judgment, patient history and presenting etiology of individual patients. However, advisable guidelines to follow include: Reserve treatment of perforator veins to patients presenting in CEAP classification 4 or greater. Identify and treat all sources of axial and truncal reflux before or at the same time as perforator treatment. Reserve VenaCure EVLT treatment of perforators to vein diameters >3-4mm or to smaller veins clearly identified as incompetent by Duplex Ultrasound. Although perforator veins are located throughout the leg, those that become clinically significant in terms of chronic venous insufficiency (CVI) are most commonly located on the medial aspect of the thigh or calf and the perimalleolar region. Incompetent perforator veins in these regions may be associated with severe sequelae of CVI for example: lipodermatolsclerosis and ulceration.

CONTRAINDICATIONS
Patients with thrombus in the vein segment to be treated. Patients with an inability to ambulate. Patients with severe arterial disease. Patients with deep vein thrombosis or have a history of DVT’s. Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

POTENTIAL COMPLICATIONS
Potential complications include but are not limited to the following: Vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, parasthesia, skin burns, and thrombophlebitis.

The VenaCure EVLT procedure can be performed under local anesthesia in the physician’s office or as an outpatient treatment. The VenaCure EVLT procedure must only be performed by a qualified physician who has received specialized training in the techniques described.

Sotradecol®

INDICATIONS
Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

CONTRAINDICATIONS
Sotradecol (sodium tetradecyl sulfate injection) is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.

WARNINGS
Sotradecol (sodium tetradecyl sulfate injection) should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important.

Emergency resuscitation equipment should be immediately available. Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of Sotradecol be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.

Because of the danger of thrombosis extension into the deep venous system, thorough preinjection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.

The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.

PRECAUTIONS
Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease).

DRUG INTERACTIONS
No well-controlled studies have been performed on patients taking antiovulatory agents. The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with Sotradecol. (See ADVERSE REACTIONS section). Heparin should not be included in the same syringe as Sotradecol, since the two are incompatible.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
When tested in the L5178YTK +/- mouse lymphoma assay, sodium tetradecyl sulfate did not induce a dose-related increase in the frequency of thymidine kinase-deficient mutants and, therefore, was judged to be nonmutagenic in this system. However, no long-term animal carcinogenicity studies with sodium tetradecyl sulfate have been performed.

PREGNANCY
Teratogenic Effects – Pregnancy Category C. Animal reproduction studies have not been conducted with Sotradecol. It is also not known whether Sotradecol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sotradecol should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.

NURSING MOTHERS
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sotradecol is administered to a nursing woman.

PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS
Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section).

Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section). At least six deaths have been reported with the use of Sotradecol. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol. (See WARNINGS section).

One death has been reported in a patient who received Sotradecol and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives.