Thursday, April 16, 2015

News: World's largest orthopedics contract manufacturer closing two plants

Tecomet | Solving Extreme Challenges with Precision Technology
Tecomet is slated to close plants in New Bedford, MA, and Avilla, IN, at a cost of more than 300 jobs, a regulatory filing shows. The move comes months after contract manufacturerSymmetry Medical was acquired by privately held Tecomet, in a move that created the world largest contract orthopedic manufacture, with a presence in 5 countries across the world. At the time of the deal,Tecomet said it had 18 facilities, but that number will soon be reduced to 16.

The company said both former Symmetry Medical facilities "struggled to make a profit." The 129 Indiana layoffs will occur in three waves, with the final cuts occurring on December 15, 2015, according to the filing. The Boston Globe reports that a separate filing with the Massachusetts state government indicates that 190 layoffs are planned in New Bedford.
Tecomet said the work will be transferred to its other manufacturing locations. One of them will be Warsaw, IN. Local outlet The Journal Gazette reports that the facility is being expanded in what's known as the orthopedics capital of the world.Biomet and Zimmer ($ZMH) are both based out of Warsaw, while Medtronic ($MDT) and Johnson & Johnson's ($JNJDePuy have facilities there as well.

In 2012, Tecomet acquired Teleflex's ($TFX) orthopedics manufacturing business for $45 million. The company's medical manufacturing ranges from artificial hips to cranial implants, artificial discs for the spine and components of cardiovascular implants. Tecomet also manufactures components for the aerospace and industrial applications.

Published at - Fiercemedicaldevices

News: Zimmer Announces Extension of Outside Date for the Pending Biomet Merger

WARSAW, Ind., April 13, 2015 /PRNewswire/ -- Zimmer Holdings, Inc. (NYSE and SIX: ZMH) ("Zimmer") announced today that the "outside date" for completing the proposed merger pursuant to the Agreement and Plan of Merger (the "Merger Agreement"), dated April 24, 2014, among Zimmer, Owl Merger Sub, Inc. and LVB Acquisition, Inc., the parent company of Biomet, Inc. ("Biomet"), has been extended from April 24, 2015 to July 23, 2015.  The terms of the Merger Agreement allowed either party to extend the outside date for an additional 90 calendar days if necessary regulatory clearances under the applicable antitrust laws of certain jurisdictions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, have not been obtained.

ZIMMER, INC. LOGO
As previously announced, the European Commission has conditionally cleared Zimmer's proposed acquisition of Biomet.  The Japan Fair Trade Commission also has granted clearance of the pending transaction.  The transaction remains subject to clearance by the U.S. Federal Trade Commission (the "FTC"), as well as other customary closing conditions.  Zimmer continues to work closely with the FTC and expects to receive clearance for the proposed transaction from the FTC by the end of April or shortly thereafter.
Under the terms of the Merger Agreement, Zimmer will acquire Biomet in a cash and stock transaction valued at approximately $13.35 billion, including assumption of net debt.
About Zimmer
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants and related surgical products.  Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer's 2014 sales were approximately $4.7 billion.  Zimmer is supported by the efforts of more than 9,000 employees worldwide.
Published at - Zimmer Inc.

Saturday, April 11, 2015

News: Zimmer recalls Persona knee implant component

Zimmer recalls a part used in 1 of its knee implant systems, the Persona trabecular metal tibial plate, on complaints of loosening and that it would not show up on X-rays.
Zimmer recalls knee implant component
Zimmer (NYSE:ZMH) is recalling a crucial component of 1 of its knee implant systems because of increased complaints that the part was loosening and wouldn't show up on X-rays.
The FDA slapped a Class II label on the recall, signifying major safety risks, of Zimmer's Persona trabecular metal tibial plates.
The FDA said that Zimmer is pursuing a voluntary recall of the part after reports of loosening and complaints of "radiolucent lines" – meaning the part was transparent in X-rays.
It's a global recall, affecting much of the U.S., Canada, Australia, New Zealand, Korea, Austria, Germany, Italy, South Africa, Switzerland and the United Arab Emirates, according to the federal safety watchdog.
In the U.S., the part was distributed to a number of VA Medical Centers in states including South Dakota, Georgia, Alabama, Massachusetts, New York, Ohio, Indiana, Pennsylvania, Missouri and California, the FDA said.
All sizes and lots of the affected devices are being removed from distribution and Zimmer issued urgent medical device recall notices to affected distributors, hospitals and surgeons Feb. 16.

News: FDA finalizes fast-track approval for medical devices

The FDA issues final guidance on its new fast-track approval protocol for medical devices that target life-threatening or debilitating conditions.
FDA finalizes fast-track approval for medical devices
The FDA today issued its final guidance on a new, fast-track approval protocol for medical devices aimed at deadly or debilitating illnesses with no treatment options.
The safety watchdog's Center for Devices & Radiological Health said its Expedited Access Program allows companies with devices for life-threatening or irreversibly debilitating conditions, that would normally be subject to the stringent pre-market approval process or the de novo clearance program, to ask for fast-tracking at the agency.
part from devices addressing unmet needs, breakthrough technologies that provide "a clinically meaningful advantage over existing legally marketed technology" are also eligible for the EAP track, the FDA said. Devices that offer "significant, clinically meaningful advantages over existing legally marketed alternatives" or whose availability is in the best interest of patients are also candidates, the agency said. Breakthrough technologies can include new products and new applications for existing products, the FDA said.
"The data development plan will shift premarket data collection to the postmarket setting, to the extent appropriate, taking into account the public health benefit of these devices, while still meeting the U.S. approval standard of reasonable assurance of safety and effectiveness," CDRH director Dr. Jeffrey Shuren wrote today in a blog post. "The premarket data must be adequate to support FDA’s high standard for premarket review but can include data based on an intermediate endpoint or a surrogate endpoint reasonably likely to predict clinical benefit."
The FDA can accept a greater degree of uncertainty if it decides a device's benefits outweigh the risks, Shuren wrote, if the risk "is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device."
Drug-device combinations "may raise unique scientific and regulatory challenges," according to the safety bureau, meaning that companies seeking the EAP track for those devices should enquire as early as possible about its feasibility.

Study: Physical therapy equals surgery in lumbar spinal stenosis



The results indicate that physical therapy might be indicated as a 1st-line treatment for Lumbar Spinal Stenosis (LSS), Dr. Jeffrey Katz of Boston's Brigham & Women's Hospital wrote in an editorial accompanying the research.Patients with lumbar spinal stenosis who followed a specified course of physical therapy fared just as well as patients treated with surgery, according to a study published in the Annals of Internal Medicine

Image result for physical therapy
A study comparing physical therapy and surgery in treating lumbar spinal stenosis finds that Physical Therapy (PT) is as effective as surgical decompression.
The 169-patient study, conducted from 2000 to 2007, randomly assigned patients who signed a surgical release to either the PT cohort or the surgery group. The PT regimen consisted of twice-weekly, standardized visits for 6 weeks; the surgical-arm patients underwent standard posterior decompressive laminectomy.
There were no differences after treatment between the 2 groups, according to the study, with both showing improvement beginning at 10 weeks and continuing through 26 weeks. The improvements were maintained for both groups through the 2-year follow up, according to the study, which was led by Anthony Delitto of the University of Pittsburgh.
In his accompanying editorial, Katz said other studies show that the benefits of surgery decline over time, suggesting that PT might be the best option for initial treatment.
"From a clinical standpoint, Delitto and colleagues' trial suggests that a strategy of starting with an active, standardized PT regimen results in similar outcomes to immediate decompressive surgery over the first several years," he wrote. "Taken together, these data suggest that patients with LSS should be offered a rigorous, standardized PT regimen. Those who do not improve and ultimately consider surgery should be informed that the benefits are likely to diminish over time. Finally, because long-term outcomes are similar for both treatments yet short-term risks differ, patient preferences should weigh heavily in the decision of whether to have surgery for LSS."