Perforator Vein Ablation Kit

Treat More Veins with AngioDynamics’ Laser Ablation Kit for IPV

Incompetent Perforator Veins (IPV) can now be easily treated with our Perforator Vein Ablation Kit (PVAK)

Incompetent Perforator Veins (IPV) associated with Chronic Venous Insufficiency (CVI) are linked to venous hypertension, severe sequelae of CVI(1), and the development of leg ulcers(2). Treatment of CVI/IPV can lead to reduced recurrence rates for venous ulcers(3). With 20% of limbs with CVI also displaying IPV (66% when significant skin changes are also present)(4,5), this represents a large opportunity to expand the range of venous disease treated in your practice.

Features & Benefits

• 21 gauge venous access needle for easy, atraumatic access
• 0.018” guidewire to navigate small, tortuous perforator veins with our custom-designed short, “floppy” tip
• 10cm x 4Fr introducer sheath with stiff dilator to guide the sheath into the proper subfascial plane
• 400um optical fiber with Site Marks and compression clamp to assure proper fiber positioning

Refer to full Instructions for Use on how to use this medical device.

INDICATIONS:
The D15 Plus, D30 Plus, DELTA-15 and DELTA-30 lasers and VenaCureEVLT™ 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™ 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.

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 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.

Note: Treatment of IPV requires significant experience in ultrasonography and percutaneous venous access. Ablation of IPV should be performed by physicians familiar with VenaCure EVLT™ in the treatment of GSV and other truncal veins. Physicians are highly encouraged to read the Instructions for Use included with the VenaCure EVLT Perforator Vein Ablation Kit.

Sources:
1. Iafrati M. Subfascial Endoscopic Perforator Vein Surgery. Seminars in Cutaneous Medicine and Surgery 2005;10.007 Elsevier Inc.
2. Nelzen O. Prospective study of safety, patient satisfaction, and leg ulcer healing following Saphenous and SEPS. British Journal of Surgery 2000; 87:86-91.
3. Barwell J, et al. ESCHAR Study: randomized controlled trial. The Lancet June 2004; 63:1854-59.
4. Labropoulos N, et al. Development of reflux in the perforator veins in limbs with primary venous disease. J Vasc Surg 2006; 43:558-62.
5. Myers KA, Ziegenbein RW. Duplex ultrasonography scanning for chronic venous disease: patterns of venous reflux. J Vasc Surg 1995; 21:605-12.