COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--Spectranetics Corporation today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its new VisiSheathTM Dilator Sheath device. This expands the market for VisiSheath, which recently also received CE Mark approval in Europe. The VisiSheath Dilator Sheath may be used alone as an independent sheath for dilating tissue surrounding cardiac leads, or as an enhanced outer support sheath in conjunction with compatible inner sheaths such as Spectranetics’ Laser Sheath (SLS® II), a laser-based system for removing problematic pacing and defibrillator leads.
Leads are insulated wires connecting pacemakers and defibrillators to the heart that can become infected or non-functional over time. The Heart Rhythm Society Expert Consensus on Facilities, Training, Indications and Patient Management issued earlier this year recommends lead removal following such complications. The VisiSheath Dilator Sheath is an enhanced tool to help physicians free cardiac leads from binding scar tissue that makes removal challenging by dilating the affected area. The VisiSheath device employs unique gold-coated steel marker bands to provide physicians with more than 200 percent better fluoroscopic visibility of the device tip than standard Teflon® or polypropylene sheaths. An advanced multi-layer construction and robust tip design deliver high performance for navigating over leads and dilating tissue.
The first human use of the VisiSheath device took place in Sweden in a laser-assisted lead removal procedure performed by Dr. Charles Kennergren, Associate Professor of Cardiothoracic Surgery at the Sahlgrenska University Hospital in Gothenburg. Dr. Kennegren commented, “VisiSheath’s fluoroscopic visibility is excellent. I found the device especially useful in supporting the laser sheath through the subclavian vein, reducing friction from the clavicle and increasing the tactile feel when maneuvering the laser sheath. For physicians that do not use the laser sheath, I believe this device will provide a nice, high-performance alternative to existing simple plastic sheaths.”
Following initial introduction of VisiSheath into the U.S. market, Dr. Bruce Wilkoff, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic, utilized it as an outer sheath for the SLS II laser sheath in a laser-assisted lead removal procedure at Cleveland Clinic. Dr. Wilkoff stated, “It is valuable for extraction sheaths to be visible on fluoroscopy and to provide for torque control. These characteristics favor safe advancement of extraction sheaths through fibrotic tissues.”
Both Dr. Kennergren and Dr. Wilkoff are members of the physician medical advisory board for Spectranetics.
Safe, Effective Treatment for Patients with Problematic Pacemaker and Defibrillator Leads
More than two million Americans rely on a pacemaker or defibrillator to regulate their heart beat. These devices rely on insulated wires, called cardiac leads, to deliver electrical impulses to the heart and detect the heart’s electrical activity. Physicians are recommended to remove cardiac leads when complications occur, such as infection or malfunction. Spectranetics’ excimer laser technology offers a safe means to remove cardiac leads by using pulsed bursts of ultraviolet (UV) light energy to break down scar tissue holding leads in place, thereby enabling effective removal. The newly FDA-cleared VisiSheath Dilator Sheath device will complement the laser-based system as an outer support sheath. Additionally, it will offer a non-laser option to mechanically dilate scar tissue for physicians who do not use laser assistance to manage all of their patients with lead complications.
“As more patients receive pacemakers and defibrillators at a young age, there is a growing need to address complications associated with problematic leads,” said Emile Geisenheimer, Chairman, President and Chief Executive Officer at Spectranetics. “The VisiSheath Dilator Sheath represents an important advancement in the treatment of lead-related complications.”
To provide options for different clinical scenarios and user preferences, the VisiSheath Dilator Sheath device is offered in nine sizes, comprised of combinations of three different diameters and three different lengths.
About Spectranetics
Spectranetics manufactures and markets the only CVX-300® Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide.
The Company’s Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.
The Lead Management (LM) product line includes Excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include adverse results of the FDA and Immigration and Customs Enforcement investigation, adverse results of the securities litigation or the stockholder derivative litigation in which the Company or any of its officers or directors is a party, insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with those proceedings, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital and has rendered our investments in auction rate securities illiquid, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of the Company’s strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications, and the timeliness of any approvals, market acceptance of new products or applications, including the VisiSheath Dilator Sheath, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Company’s relocation and consolidation of its manufacturing operations, and price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company’s previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Media Contacts: Schwartz Communications Andrew Law/Krystin Hayward, 781-684-0770 spectranetics@schwartz-pr.com or Investor Contacts: Lippert/Heilshorn & Associates, Inc. Don Markley or Bruce Voss, 310-691-7100 dmarkley@lhai.com
