Spectranetics (NSDQ:SPNC) said today it won FDA 510(k) clearance for its Bridge occlusion balloon designed to temporarily occlude vessels during cardiac lead extraction procedures.
The Colorado Springs, Colo.-based company’s Bridge balloon is designed to reduce blood loss in the event of a tear and to provide a “bridge” to surgical intervention.
“The Bridge occlusion balloon represents the biggest breakthrough in lead management in the past 20 years. I believe Bridge will have a major impact on the field. It is imperative to have the right tools and techniques to support procedural safety. Bridge empowers extractors to take life-saving action while transitioning to surgical repair, driving positive patient outcomes,” lead physician investigator Dr. Jude Clancy of Yale Medical Group said in prepared remarks.
Spectranetics said it planned a controlled market release for the newly cleared product, with a full launch slated for early May to sync up with the Heart Rhythm Society’s annual meeting in San Francisco.
“Spectranetics was founded on a commitment to safe, predictable, responsible, life-saving medical procedures, and Bridge further affirms that commitment. We constantly innovate for safety, through research and development of new tools and techniques and the most comprehensive physician training programs available. Bridge represents another step in Spectranetics’ mission to improve patient care through proactive lead management,” sales and marketing senior veep Donna Ford-Serbu said in a press release.
SVC tears occur in less than 0.5% of lead extraction procedures, but upon tearing the balloon is designed to deploy in less than 2 minutes to provide temporary occlusion prior to a critical surgical intervention.
“The Bridge occlusion balloon is a game changer for extractors as well as the cardiac surgeons who support them. With Bridge in place, the surgeon has a clear field of view of the repair site and can quickly take the most appropriate steps for the patient,” Dr. Roger Carrillo of Florida’s University of Miami Hospital said in a prepared statement.
In November, Spectranetics said it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis.
The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said.