Spectranetics’ Bridge™ Occlusion Balloon Clinical Experience to Present at Heart Rhythm 2017

In-booth advanced training focuses on lead extraction workflow

The Spectranetics Corporation, an industry leader in lead management, will feature the Bridge™ Occlusion Balloon’s year-one clinical experience Heart Rhythm 2017, Heart Rhythm Society’s 38th Annual Scientific Sessions, May 10-13, 2017, in Chicago, IL.
The Bridge Occlusion Balloon is designed to dramatically reduce blood loss in the rare event of a tear in the superior vena cava (SVC) during lead extraction procedures providing a bridge to surgical repair. In the year since its introduction, Bridge is credited for assisting in saving numerous lives.
A variety of presentations and in-booth experiences are available to give physicians more information about the life-saving potential of Bridge:

Fri., May 12, 9 – 10 a.m., Room 270 (Level 2 in McCormick Place West)
Late-Breaking Clinical Trial (LBCT) Press Conference
• Includes eight-minute briefing from study by Roger G. Carrillo, MD, Chief of Surgical Electrophysiology, University of Miami Hospital, Miami, Fla., LBCT: Compliant Endovascular Balloon Reduces the Lethality of Superior Vena Cava Tears During Transvenous Lead Extractions (see below).

Fri., May 12, 4:30 – 6 p.m., Late-Breaking Clinical Trial, LBCT Session Room
Compliant Endovascular Balloon Reduces the Lethality of Superior Vena Cava Tears During Transvenous Lead Extractions
• Roger G. Carrillo, MD, Chief of Surgical Electrophysiology, University of Miami Hospital, Miami, Fla.

Wed. May 10, 3:30-5:30 p.m., Thurs. May 11 and Friday, May 12, Booth 1213, 9 a.m. – 4:30 p.m., every hour on the half hour.
Bridge Occlusion Balloon In-booth Advanced Training
• View a demonstration or go hands-on with a realistic heart model to learn how Bridge is prepared and deployed. Includes recommendations for incorporating Bridge into the lead extraction protocol and the opportunity for physicians to participate in timed practice drills.

Bridge Occlusion Balloon product details:
• The Bridge Occlusion Balloon deploys in under two minutes¹, occluding an SVC tear and stemming blood loss by 90%, on average² in 90% of patients³.
• When deployed, the Bridge Occlusion Balloon provides acceptable hemostasis for at least 30 minutes⁴.
• The device is intended to provide temporary occlusion while the patient is transitioned to surgical repair, providing a “bridge” to surgical repair.
Attendees will be able to experience Spectranetics’ full portfolio of lead extraction options, including the Bridge Occlusion Balloon and TightRail™ Sub-C, a new mechanical device specifically designed for calcific and fibrotic challenges of the subclavian vessel, in Booth 1231.

Quotes:
• Roger G. Carrillo, MD, Chief of Surgical Electrophysiology, University of Miami Hospital, Miami, Fla.: “Bridge is a path to better patient outcomes in lead extraction. The compliance of the balloon makes the difference. I now consider the device an essential part of the clinical workflow.”
• Bruce Wilkoff, MD, Cleveland Clinic: “Bridge is now part of our standard lead extraction protocol.”
• Donna Ford-Serbu, Senior Vice President, Lead Management Sales and Marketing at Spectranetics: “In just one year, the Bridge Occlusion Balloon is credited for saving lives. With our long-standing focus on clinical success of cardiac lead extraction, Bridge demonstrates our commitment to raising the bar on safe and responsible lead management through innovation.”

About Lead Management
There are more than 7 million pacemakers and implantable cardiac defibrillators (ICDs) implanted worldwide, 700,000 new devices implanted each year and 1.5 million new leads implanted annually. These devices and the leads that connect them to the heart need ongoing management and maintenance. Sometimes this includes removal due to lead damage, lead or device infection, or manufacturer advisory. Laser lead extraction has been a treatment option for more than 20 years. Multiple studies show a procedural success rate of more than 97% demonstrating safety, effectiveness and efficiency of laser lead removal. In 2014, Spectranetics introduced mechanical tools into its comprehensive portfolio of lead management solutions. In 2016, the Bridge Occlusion Balloon launched to address the rare event of a tear in the superior vena cava (SVC).

About Spectranetics
Spectranetics develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.

The Company’s Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee, the AngioSculpt® scoring balloon used in both peripheral and coronary procedures and Stellarex™ drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014.
The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads, including the Bridge™ Occlusion Balloon.

For more information, visit www.spectranetics.com.

¹ Document on file D027562. Bridge can be fully deployed in under one minute (53 seconds) in an animal model when pre-positioned on a guidewire, or in under two minutes (1 minute, 46 seconds) when not pre-positioned.

² Document on file D027561. When deployed, the Bridge occlusion balloon reduces blood loss by up to 90%, on average, in an animal model of an SVC tear. Testing was conducted in a heparinzed porcine model which has shorter SVC length than is typical in humans. A balloon design scaled for use specifically in the porcine model was used in generating this data.
³ Document on file D027563. The balloon will cover the length and diameter of the SVC in 90% of the population as determined by analysis of 52 patients (N=52, % Male=48.1, Average Age 47.1 ± 16.5, Age Range 63 (18 to 81 years), Average Height 170.8cm ± 10.6, Height Range 40.6cm (152.4 to 193cm), Average BMI 29.8 ± 7.2, BMI Range 32.1 (18.2 to 50.3)).
⁴ Document on file, D026197. In an animal model with SVC tears up to 3.5 cm, with 2 pacing leads and 1 ICD lead.