Natick, Mass.-based Boston Scientific won CE Mark approval for its Blazer open-irrigated, a radiofrequency ablation (RFA) catheter for treating atrial fibrillation and other arrhythmias.
The new open-irrigated catheter integrates the company’s Blazer catheter platform with its "Total Tip Cooling" design, which is intended to consistently cool the tip electrode during RFA energy delivery, according to the company. Boston Scientific also announced the first use of the product in Europe and plans to launch the the device this quarter in certain European Union countries.
Just one day before BSX made broke the news about its Blazer catheter, Medtronic said it landed FDA approval for a "mapping" catheter designed for assessment of pulmonary vein isolation during paroxysmal atrial fibrillation (PAF) treatments.
Medtronic’s device, named Achieve, is an intra-cardiac electrophysiology diagnostic catheter, and is approved only for use with the company’s Arctic Front cardiac cryoablation system.
The Fridley, Minn.-based company’s Arctic Front is the only cryoballoon ablation treatment that is approved in the United States for paroxysmal AF, an irregular heartbeat that affects people only intermittently and generally stops in less than seven days.
The Achieve "enables physicians to engage in real-time evaluation of pulmonary vein isolation during the Arctic Front procedure," Medtronic AF Solutions division vice president Reggie Groves said in prepared remarks.
Last week, the first patient procedure in the U.S. using the new catheter was performed by Dr. Robert Kowal, an electrophysiologist at the Baylor Heart & Vascular Hospital in Dallas.
Roughly 15,000 Arctic Front procedures have been performed worldwide, including 1,000 procedures with the Achieve catheter in Europe, according to Medtronic.
According to research published recently in Circulation: Cardiovascular Quality and Outcomes, patients with atrial fibrillation add $26 billion to the U.S.’s health care costs annually.
Of that $26 billion total, $6 billion goes to AF care, $9.9 billion winds up being spent on other cardiovascular risk factors or disease and $10.1 billion is spent on treating non-cardiovascular health problems. In addition, the AF patients studied were hospitalized twice as often, had three times the rate of multiple hospitalizations, and had four times as many cardiovascular admissions as patients without the condition, according to a statement from the American Heart Association.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Femasys wins FDA 510(k) clearance fallopian tube evaluation device
Femasys Inc. won 510(k) clearance for the FemVue Saline-Air Device for a diagnostic Sono HSG allowing physicians to evaluate a woman’s fallopian tubes with existing ultrasound equipment. The product allows for a non-radiation Sono HSG procedure to be performed quickly by a woman’s gynecologist or infertility specialist in the office.
- Idaho Technology receives FDA clearance for FilmArray
Idaho Technology Inc. announced that the FDA issued a 510(k) clearance for the FilmArray instrument and the FilmArray Respiratory Panel. The FilmArray Respiratory Panel is a multiplexed nucleic acid test designed for the simultaneous detection of 15 respiratory viruses in 1 hour. It detects viral nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections.
- Spring-Set wins FDA 510(k) for Spring Universal infusion sets
D. Medical Industries Ltd. announced that the FDA has granted Spring-Set Health Solutions Ltd., 510(k) clearance to market its Spring Universal Infusion Sets in the U.S.
- Kelyniam receives FDA clearance for personalized cranial implants
Kelyniam Global Inc. received clearance from the FDA to begin marketing its Patient Specific Custom Cranial Implants. The Kelyniam Custom Skull Implants are designed and manufactured for each individual patient to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects.