C.R. Bard (NYSE:BCR) has until the end of the week to consummate its $15 million deal for Spire Corp.’s (NSDQ:SPIR) hemodialysis catheter business — unless the companies decide to postpone the buyout for the fourth time.
The Food & Drug Administration slapped a Class I recall on Cardiovascular Systems Inc.’s recall of its ViperSheath catheter introducer.
The Food & Drug Administration issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures.
The device, a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, “may spontaneously rupture during surgery,” according to the FDA recall. Class I recalls are the watchdog agency’s most serious, used when there’s a “reasonable probability that use of these products will cause serious adverse health consequences or death.”
Cordis Corp. is recalling its Crossover sheath introducer after receiving complaints that the device, used to ease catheter insertions into the bloodstream, stretched or fractured during use.
The voluntary recall announced Oct. 27 affects all lots distributed between Aug. 14 and Sept. 23. To date, Cordis said it has received six complaints from Crossover users, with two instances of physicians needing to surgically retrieve portions of the sheath after it broke apart.
The Marlborough, Mass.-based company’s device is a visually-guided balloon catheter that uses a rotating laser to ablate the tissue surrounding the pulmonary artery’s entrance into the heart, to reduce atrial fibrillation.
The Bedford, Mass.-based company said the deal, expected to close before the end of the month, will see substantially all of the assets of the seven-year-old catheter business go to Salt Lake City-based Bard, in return for $14.9 million in cash and $100,000 to two employees as compensation for non-compete contracts.
Three of the four complaints, one for each lot, did not involve what the company called “adverse patient effects.” However, one complaint showed evidence that the patient suffered a post-procedure heart attack, but was subsequently said to be “doing well,” according to a press release.
Abbott spokesman Jonathon Hamilton told MassDevice that the total number of catheters in all four lots numbers about 550.
The Marlborough cardiac device maker said the system consists of a micro-endoscope physicians use to see within the heart and direct energy through a catheter to the fibrillating tissue in the heart’s atrial chamber.
The Marlborough device maker is developing a catheter-based system that uses lasers to treat atrial fibrillation. It’s currently in pre-marketing clinical trials under an investigational device exemption from the Food & Drug Administration.
The Wilmington radio frequency generator manufacturer said the deal extends its reach into the interventional pain management market.
Micron Catheter makes an epidural catheter used to remove scar tissue formed after back surgeries.
InfraReDx Inc.‘s optical/acoustic imaging catheter was used for the first time in patients undergoing angiography in the Netherlands.
The Burlington-based near-infrared spectroscopy maker said the device, which uses both ultrasound waves and near-infrared light to provide images of the coronary plaque believed to cause most heart attacks, can help surgeons determine not only the shape of the plaque but its composition.
That means the device can help doctors assess the likelihood of further cardiovascular problems stemming from the plaque lining patients’ blood vessels.