Boston Scientific Debuts Intravascular Image System

Intravascular imaging may just have become easier for Boston Scientific (Marlborough, MA) iLAB customers.

The company has launched a more powerful imaging device that could also reduce confusing workflows, shorten procedure times, and ease image interpretation,according to a press release. Physicians, nurses, technicians, and software design experts advised the company on the design.

The company has redesigned and enhanced the user interface and workflow of the iLab system, which includes an articulating ceiling or wall arm, two 19-inch display monitors, an imaging PC, an archiving PC, a thermal printer, a tableside controller, a motor drive unit and a power supply.

The Polaris system will support the company's intravascular ultrasound (IVUS) catheters, including coronary, peripheral and intra-cardiac echo devices. It was also designed to accommodate imaging products that the company has yet to release, including a fractional flow reserve (FFR) wire, additional IVUS catheters, and updated software and system control tools, the company said.

The Polaris system has CE Mark and FDA 510(k) clearance.

Last week, Boston Scientific announced gaining the CE Mark for its 25-mm Lotus aortic valve. Earlier this week, it announced FDA approval for its Rebel bare-metal stent.

The company has had better weeks, however. On Thursday, July 24, it reported that second-quarter earnings had plummeted 97 percent, dragged down by the cost of defending its transvaginal surgical mesh product. Boston Scientific set aside $267 pretax to increase its liability reserves for that purpose.

Vaginal mesh devices were supposed to treat urinary incontinence. However, the FDA from 2008 through 2010 received reports of thousands of serious complications, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.

Other companies that have faced lawsuits over vaginal mesh products include Endo International, Johnson & Johnson's Ethicon subsidiary, American Medical Systems, C.R. Bard, Cook Medical, and Coloplast.

Nancy Crotti is a contributor to Qmed and MPMN.

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