BSX wins FDA approval on heart devices
Natick-based Boston Scientific Corp. (BSX) has received approval for its newest defibrillators and heart failure devices, including the trademarked Dynagen Mini, Inogen Mini ICDs, and the Dynagen XF and Inogen X4 CRT-Ds.
The CRT-D devices are designed to advance patient care, employing more pacing options and the largest battery capacity in the industry, according to BSX. And the ICD Minis are the smallest and thinnest on the market, which improves patient comfort, BSX said.
ICDs and CRT-Ds are used to treat patients suffering from heart failure, and to provide protection to patients at risk of sudden cardiac death.
“With these new devices and our current line of long-lasting ICDs and CRT-Ds … we believe we offer the very best range of options for patients at risk of sudden cardiac arrest,” said Joe Fitzgerald, executive vice president and president for the Rhythm Management division of BSX.
Meanwhile, a federal court on Tuesday lifted a preliminary injunction issued in January on the sale of BSX’s Guidezilla guide extension catheter in the U.S. BSX launched sales of the catheter last July, despite an ongoing lawsuit filed by Minnesota-based Vascular Solutions Inc., alleging that the BSX design mimicked the design of its own flagship product.
The court ruled that an injunction isn’t warranted because the record of information is too incomplete at this stage of the case. Patent litigation is ongoing.
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