Carefusion, Elite Biomed issue Class I Alaris pump recalls

The FDA today issued 2 recall notices related to CareFusion‘s Alaris pumps, including 1 to CareFusion over alarm issues and another to Elite Biomedical Solutions over a flaw in a replacement frame membrane for the drug pumps.

The FDA has labeled the recalls as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

CareFusion received 108 reports of an error in which a visual and audible alarm that causes the Alaris pump to stop supplying infusion to the patient, according to the FDA.

Even if the error is cleared, the pump does not respond to key presses until the unit is completely disconnected and reconnected to the computer unit used to program, monitor and provide power to the pump, the federal watchdog said.

Failures in the syringe pump may cause delays or interruptions of therapy and can lead to serious injury or death, the FDA said. So far, CareFusion has not received any reports of permanent injury or death.

A total of 6,458 Alaris syringe pumps, model number 8110, are affected by the recall.  The recalled pumps were manufactured between March 2014 and September 2014 and distributed between March 17, 2014 and September 30, 2014. All units recalled were distributed within the U.S.

CareFusion began notifying customers of the issue July 20, saying the company would initiate repairs on the units within 60 days and advising users to sequester the pumps and use alternate units.

A 2nd Alaris recall was issued involving Elite Biomedical Solutions’ Alaris medley large volume pump frame membrane, a replacement piece for a CareFusion Alaris pump. The frame membrane is a part of the Alaris pump that prevents fluids from leaking into internal components, according to the FDA.

Elite Biomedical Solutions said it discovered that use of the replacement frame membrane could lead to over or under infusion of fluids to the patient, with the potential to cause injury or death.

A total 1,502 units distributed within the U.S. are affected by the recall, manufactured between February 20, 2015 and April 21, 2015 and distributed between February 25, 2015 and May 8, 2015, the FDA said.

Elite Biomedical Solutions began contacting customers about the issue on May 21, urging customers to quarantine any indicated products and contact any patients the parts could have been distributed to.

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MassDevice.com +3 | The top 3 medtech stories for August 26, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. Abbott denies St. Jude Medical buyout report

Abbott denied reports that it’s prepping a $25 billion offer for St. Jude Medical, but the rumor nevertheless propelled STJ shares up YY% this morning.

Investors were sparked by a Financial Times report of the potential offer. Abbott is working with banks on a cash-and-stock proffer, the newspaper report, citing people familiar with the situation. A deal between Abbott and St. Jude, which already jointly sell their cardiovascular products, would give the new entity stronger ground in negotiations with hospital customers, the newspaper reported. Read more

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2. Cardinal Health to buy NaviHealth for $410m

Cardinal Health said it paid $290 million for a majority stake in post-acute care management firm NaviHealth, in a 4-year deal worth $410 million.

The $290 million payout gives Dublin, Ohio-based Cardinal a 71% share in NaviHealth, the company said. NaviHealth’s Brentwood, Tenn.-based management team will continue to lead the business and principal investor Welsh, Carson, Anderson & Stowe will hold on to its stake, Cardinal Health said. Read more

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1. Greatbatch to buy out Lake Region Medical for $1.7B

Greatbatch said that it agreed to acquire Lake Region Medical for $1.73 billion in cash and stock.

Terms call for Frisco, Texas-based Greatbatch to pay $478 million in cash and some 5.1 million shares of stock (which closed at $49.89 per share, making that portion of the offer worth another $254.4 million). Greatbatch said it also agreed to assume $1 billion worth of Wilmington, Mass.-based Lake Region Medical’s debt Read more

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AxoGen deals 16% stake to Essex Woodlands for $17.1m

AxoGen Inc. (NSDQ:AXGN) said today it sold 4.8 million shares to investment firm Essex Woodlands, reeling in $17.1 million for Axogen and giving Essex Woodlands a 16% stake in the company.

The funds from the sale are slated to support market growth and accelerate the company’s entry into new nerve repair markets, including the development and commercialization of new nerve repair products.

“Our partnership with Essex Woodlands puts AxoGen in an excellent position to build on the momentum we are generating in the nerve repair market as well as capitalize on our numerous opportunities. Essex Woodlands is a premier, long-term focused healthcare investor and through their investment in AxoGen we now have the resources in place to execute our current business plan as well as fund expansion. Based on our current operations, we believe the investment provides AxoGen with the resources to achieve positive operating cash flow,” CEO Karen Zaderej said in a press release.

Peripheral nerve-repair focused Axogen said it would be taking on Essex Woodlands operating partner Guido Neels as a new member of its board along with the new financing.

“We are very glad to be a shareholder of AxoGen and we look forward to supporting Karen and the management team to continue AxoGen’s momentum as the leader of innovative surgical solutions for peripheral nerve injuries. We expect a very successful growth trajectory for the company,” Neels said in a prepared statement.

In June, Axogen said it enrolled the 1st subject in a clinical trial of its Avance nerve graft. The multicenter, prospective randomized Recon study will compare the Avance graft to nerve tubes currently used for bridging peripheral nerve tissue gaps, the Florida-based regenerative medicine company said.

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Boston Scientific looks to block pelvic mesh plaintiff’s bid to exclude murder conviction

Boston Scientific (NYSE:BSX) wants a federal judge to allow evidence of a pelvic mesh plaintiff’s murder conviction, arguing its relevance to her claims that its Uphold device affected her mental health.

Ramona Winebarger in 1995 pleaded guilty to murder in the death of her 1st husband and the shooting of another man. Sentenced to 35 years, she served 8, according to court documents.

After suing Boston Scientific in November 2013, Winebarger and 2nd husband Rex Winebarger asked Judge Richard Voorhees of the U.S. District Court for Western North Carolina to exclude evidence of her murder conviction, and another charge of giving a false statement. The Winebargers contended that the statute of limitations and the fact that both events stemmed from “a domestic violence situation” makes the evidence inadmissible.

Marlborough, Mass.-based Boston Scientific argued this week that Voorhees should allow the evidence, saying it goes toward her claim to have suffered mental anguish from the implantation of its Uphold vaginal support device in 2010.

“Mrs. Winebarger’s medical records, however, establish a long history of anxiety, depression, and flashbacks unrelated to her 2010 surgery. Mrs. Winebarger’s emotional history – which is necessarily intertwined with her criminal record – is directly relevant to her claimed damages,” the company argued. “Moreover, this evidence is also relevant to Mr. Winebarger’s claim for loss of consortium. Boston Scientific does not seek to impeach Mrs. Winebarger’s character for truthfulness – but rather to rebut her claim for damages.”

Boston Scientific also argued that the domestic violence claim calls her credibility into play, as it contradicts her 1995 confession in which she admitted to lying in wait at her 1st husband’s friend’s house before shooting him and wounding the friend.

“Mrs. Winebarger’s current claim that her convictions stemmed from a ‘domestic violence situation’ contradicts her earlier admission that she lied in wait for her husband and ‘had been planning [his murder] all day,'” the company contended in an August 25 court filing.

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Skyline Medical gets $15m from Dawson James

Skyline Medical said yesterday it acquired $15 million from a follow-on offering from new investor Dawson James Securities, floating 1.7 million shares of stock at $9 each.

Each share sold in the offering consists of a common share of stock, 1 share of Series B convertible preferred stock and 4 Series A warrants, according to the company.

“We are pleased to provide Skyline Medical with the capital required to expand their business and deliver on their overall strategic plan. The strength of the Skyline Medical story, combined with this unique unit structure, facilitated a successful transaction in the face of a volatile market environment. The up-listing from the OTCBB to Nasdaq should help position the company going forward with increased liquidity as well as attracting new institutional investors,” Dawson James CEO Robert Keyser Jr. said in a press release.

Funds are slated to be used to build inventory, increase research & development and expand U.S. sales and marketing, according to the Minneapolis, Minn.-based company.

Skyline Medical makes the Streamway system, designed for the collection and disposal of infectious fluids that result from surgical procedures and post-operative care, according to the company.

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J&J, PCH join forces for medtech hardware incubator

Johnson & Johnson (NYSE:JNJ) is teaming up with hardware manufacturer PCH to create a medtech hardware accelerator.

The joint operation, titled Hardware for Health, will be overseen by PCH and provide physical space, funding, and assistance designing, distributing, marketting and navigating regulatory channels for medical devices, according to the companies.

The program, based in the San Francisco, Calif. area, is accepting applications starting today, according to the Hardware for Health site.

The new accelerator is looking for applications from a wide breadth of start-ups, including early prototype companies and companies that have already produced products for the market.

“Hardware and healthcare are converging as consumers increasingly interact with health-related devices. We will help take hardware health companies to market with a one-stop program to assist with product design, manufacturing and distribution, while navigating the complex regulatory framework surrounding healthcare,” PCH Access veep David Austin said in a press release.

The program won’t be limited to only healthcare, however, with the incubator program allowing any devices related to well-being that target an area of unmet need, according to the companies.

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FTC clears Pfizer’s $15B Hospira buy

Pfizer (NYSE:PFE) said Monday it won approval from the Federal Trade Commission for its $15 billion acquisition of Hospira (NYSE:HSP).

The clearance came with a caveat –Pfizer must divest itself of its Acetylcysteine, Clindamycin, Voriconazole and Melphalan sterile injectable assets, according to the company.

The news from the FTC came August 21, according to an SEC filing from Hospira, and leaves the company with only 1 post-clearance waiting period in a single foreign jurisdiction, though the region was not specified.

Pfizer also announced that Brazil has given the merger the thumbs up.

“We are pleased to have received these final regulatory approvals for our pending acquisition of Hospira. We now look forward to combining our two companies and expect the transaction to close in early September,” CEO Ian Read said in a press release.

Pfizer, maker of impotence treatment Viagra and cholesterol drug Lipitor, is making its biggest-ever acquisition aimed at expanding its portfolio of generic injectable drugs and copies of biotech medicines.

Hospira makes generic versions of injectable drugs used in hospitals, pumps to deliver such medicine and also sells biosimilars or copies of biotech drugs.

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