January’s top stories: Carlyle's $4.15bn acquistion, Edwards Lifesciences’ approval

The Carlyle Group agreed to buy Johnson & Johnson's Ortho-Clinical Diagnostics (OCD) business for $4.15bn, while Edwards Lifesciences obtained CE Mark approval for Sapien 3 transcatheter aortic valve. Medicaldevice-network.com wraps-up the key headlines from January 2014.


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Carlyle Group to buy Johnson & Johnson's diagnostic unit for $4.15bn

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The Carlyle Group agreed to buy Johnson & Johnson's Ortho-Clinical Diagnostics (OCD) business for $4.15bn.

The transaction is subject to customary regulatory approvals and is slated to close in the middle of 2014.

With this acquisition, Carlyle plans to tap into emerging and established markets and make accelerated investments in research and product development.

Edwards Lifesciences obtains CE Mark for Sapien 3 transcatheter aortic valve

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US-based Edwards Lifesciences obtained CE Mark approval in Europe for Sapien 3 valve, the latest in its line of Sapien transcatheter aortic valve implantation systems.

The company is now initiating the launch of its Sapien 3 transcatheter aortic valve in the EU.

The Edwards Sapien 3 valve features an outer skirt, a cuff of fabric surrounding the valve frame, which prevents valve leakage.

Medtronic obtains FDA clearance for full-body MRI with SureScan pacing systems

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US-based Medtronic obtained expanded approval from the US Food and Drug Administration (FDA) for its SureScan pacing systems, which have been branded safe for magnetic resonance imaging (MRI) scans positioned on any region of the body.

These are reportedly the first and only pacing systems in the US that have been approved by the FDA for use with MRI.

With this new approval, patients implanted with the Advisa DR MRI or Revo MRI SureScan pacing systems can undergo MRI scans without positioning restrictions, including the chest area, which had previously been restricted.

Covidien obtains FDA 510(k) clearance for its LigaSure laparoscopic surgical device

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Covidien received the US Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider, designed to improve efficiency during laparoscopic and open surgical procedures.

It combines three surgical tools, a Maryland dissector, or a curved jaw used to manipulate tissue; an atraumatic tissue grasper; and cold surgical scissors. The device allows surgeons to seal and cut tissue with fewer steps and reduced instrument exchanges.

Covidien Advanced Surgical president Chris Barry said: "The LigaSure Maryland jaw offers surgeons an efficient, versatile and multifunctional option for one-step sealing and further demonstrates Covidien's commitment to expand energy device options with solutions targeted at specific procedures and surgeon use needs."

BioCardia gets approval for Helix 953L catheter in EU

BioCardia obtained CE Mark approval in the EU for its Helix 953L catheter as part of its Helix transendocardial delivery system for infusion of biologics to the heart.

The Helix 953L catheter, which is compatible with smaller hearts, has been optimised for larger, dilated hearts.

According to BioCardia, the new catheter does not require biotherapeutic programmes already using the Helix system for delivery to develop new compatibility data.

Ocular Therapeutix obtains FDA clearance for ReSure sealant

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Ocular Therapeutix obtained approval from the US Food and Drug Administration (FDA) for its ReSure sealant, indicated for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery.

Approval allows Ocular Therapeutix to market its ReSure sealant, a polyethylene glycol (PEG)-based hydrogel, in the US.

Ocular Therapeutix claims that the ReSure sealant is the first and only sealant that is FDA-approved for ophthalmic use.


CareFusion closes $500m acquisition of Vital Signs from GE Healthcare

CareFusion completed the acquisition of the Vital Signs division from GE Healthcare in the US, China and other specific areas.

In November 2013, the company signed a definitive agreement with GE Healthcare as part of its strategic plans to expand its respiratory care and anaesthesiology businesses to purchase Vital Signs for $500m.

In connection with this first closing, CareFusion paid GE Healthcare approximately $470m in cash.

K2M obtains FDA 510(k) approval for Cayman minimally invasive system

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Spinal device manufacturer K2M received 510(k) approval from the US Food and Drug Administration (FDA) for its Cayman minimally invasive (MI) system.

The Cayman MI system provides simplified solution to address fractures, tumours, and degenerative conditions in the anterior and lateral spinal column.

The single-level, lateral plate system is specifically designed for insertion through the Ravine lateral access system's true muscle-splitting Retractor. The system's stackable design allows for one-level and multi-level constructs.