April's top stories: Zimmer’s $13.35bn deal, FDA clears first HPV test

Zimmer signed a definitive agreement to acquire Biomet in a $13.35bn deal, while the USFDA cleared the first human papillomavirus test for primary cervical cancer screening. Medicaldevice-network.com wraps-up the key headlines from April 2014.


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Zimmer to acquire Biomet in $13.35bn deal

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Orthopaedic device maker Zimmer signed a signed a definitive agreement to acquire Biomet in a cash-and-stock deal valued at $13.35bn, including the assumption of net debt.

Subject to customary closing conditions and regulatory approvals, the deal is expected to close in the first quarter of 2015.

It is expected to form an orthopaedics entity in the $45bn musculoskeletal industry with a broad portfolio of products, technologies and services.

Medicrea launches first patient-specific spinal rod system in Europe


Surgical technologies developer the Medicrea group launched the UNiD, the world's first patient-specific spinal osteosynthesis rod system in Europe.

French spinal surgeons have successfully implanted the customised UNiD rods into 43 patients to correct severe spinal deformities.

The first surgical operation using UNiD was carried out on 18 September 2013 by Dr Vincent FIERE, an orthopaedic surgeon at the Jean Mermoz hospital in Lyon, France.


USFDA clears first human papillomavirus test for primary cervical cancer screening


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Switzerland-based Roche received US Food and Drug Administration (FDA) clearance for its cobas HPV (Human Papillomavirus) test as a first-line primary screening for cervical cancer in women 25 and older.

HPV causes nearly all cases of cervical cancer.

The test can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer and also provides information about the patient's future risk for developing the disease.

Sorin's sutureless aortic valve Perceval gets CE Mark approval for new indication

Sorin Group obtained extended CE Mark approval for its sutureless aortic valve Perceval to include patients with aortic stenosis or steno-insufficiency who are younger than 65 years old.

Until now, only patients older than 65 years of age could benefit from the Perceval technology.

Perceval is a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery.

Edwards Lifesciences wins US sales injunction against Medtronic's CoreValve system


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Edwards Lifesciences secured a preliminary injunction from the Federal District Court of Delaware to prevent Medtronic from selling its CoreValve transcatheter aortic valve implantation system in the US.

The preliminary order will become effective in seven business days. Medtronic is currently appealing the court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued.

At the conclusion of the hearing, the court ordered Edwards Lifesciences and Medtronic to enter discussions immediately to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make clinical judgments on the appropriate device to implant (CoreValve or the Edwards' SAPIEN valves) in patients, free from limitations of the injunction.

Abbott wins FDA clearance for ARCHITECT clinical chemistry haemoglobin A1c test

Abbott received 510(k) clearance from the US Food and Drug Administration (FDA) for its new ARCHITECT clinical chemistry haemoglobin A1c (HbA1c) test, designed to aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.

The fully automated Abbott ARCHITECT HbA1c assay is used in clinical laboratories for the quantitative determination of percent haemoglobin A1c (% HbA1c) or the haemoglobin A1c concentration (mmol/mol) in human whole blood and haemolysate on the ARCHITECT c8000 system.

Percent HbA1c measurements are used in the clinical management of diabetes to assess long-term diabetic control in individuals with diabetes mellitus.

First US patients receive ICDs in Biotronik's ProMRI study


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Germany-based Biotronik announced that the first US patients have received its new Iforia implantable cardioverter-defibrillators (ICDs).

The ICDs were implanted soon after the company received US Food and Drug Administration (FDA) approval for a new phase of its ongoing ProMRI trial. The new phase is investigating the safety of ICDs in the MRI environment.

The company has performed its initial ICD surgeries for the study at hospitals in Connecticut, Pennsylvania, North Carolina, Michigan, Virginia, New York and Oregon, generally involving its Iforia devices.

Federal court postpones injunction on Medtronic's CoreValve system in US

The Federal Circuit Court of Appeals granted a request from Medtronic to suspend the preliminary injunction that was ordered on 11 April to limit the sale of its CoreValve system in the US.

According to the company, the injunction was previously scheduled to take effect on 23 April, and will now only occur if the appellate court rules that it was properly granted.

Last week, the Court of Appeals agreed to an expedited appeal of the injunction and the last appeal brief is due on 19 June.