Breakthrough Bridge™ Occlusion Balloon Rescue Device Featured at Cardiostim 2016 Late-Breaking Devices

Jude Clancy, MD, Director of the Lead Management Program, Yale-New Haven Hospital, New Haven, Conn., United States, will present a clinical evaluation of the Bridge Occlusion Balloon, a potentially life-saving technology for cardiac lead extraction procedures, at Cardiostim EHRA Europace, June 8 - 11, 2016, in Nice, France, as part of the session's Late-Breaking Devices.

The Bridge Occlusion Balloon, manufactured by The Spectranetics Corporation, received CE mark in May.  Bridge launched in the U.S. at Heart Rhythm Society's 37th Scientific Sessions in May 2016, where Dr. Clancy called it "the biggest breakthrough in lead management since the laser was introduced more than 20 years ago."

Cardiostim presentation details:

Thurs., June 9, 11 a.m., Session 102, Late-Breaking Devices
Evaluation of the Bridge™ Occlusion Balloon in Intact SVC in Patients Undergoing Lead Extraction Procedures

Presenter:      
Jude Clancy, MD, Director of the Lead Management Program, Yale-New Haven Hospital,  New Haven, Conn.

Description:    
This U.S.-based prospective, multi-center, observational study is to evaluate the use of Spectranetics' Bridge Occlusion Balloon in an intact SVC in patients undergoing a lead extraction procedure. The study, funded by SPNC and led by principal investigator Dr. Clancy, will be performed in a non-emergent setting in order to evaluate best practices for integration of the new technology into clinical practice.

The objective of the study is to determine the effect of the Bridge Occlusion Balloon on patient preparation, clinical workflow, ease of insertion, positioning and deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy. Evaluation of these factors will build a more robust clinical workflow with the goal of better patient outcomes in the case of an SVC tear.

Product details:
·       The Bridge Occlusion Balloon is a highly compliant balloon that received FDA clearance in February 2016 and CE Mark in May 2016.
·       Bridge is designed to dramatically reduce blood loss in the rare event of a tear in the superior vena cava (SVC) during lead extraction procedures.
·       Despite the rarity of an SVC tear during a lead extraction procedure (0.5%5,6), it can be a deterrent to performing or recommending the procedure.
·       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.

Cardiostim attendees will be able to experience Spectranetics' full portfolio of lead extraction options, including demonstrations of the Bridge Occlusion Balloon, in Booth D23/E19.
 

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.
 
About Spectranetics
The Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are available 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 the 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.

For more information, view www.spnc.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.
⁵ Wazni, O et al. (2010). Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. Feb 9;55(6):579-86.
⁶ Brunner, MP. et al. (2014). Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. Mar;11(3):419-25.