Netherlands Adopts US FDA-based UDI System for Medical Devices
A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s Unique Device Identification (UDI) system.
According to the post, Dutch hospitals agreed to use UDI codes exclusively for identification and traceability of medical devices, and industry promised to place only UDI codes on device labels. According to the Emergo post, this means that every manufacturer that wants their devices used in Dutch hospitals now needs to provide UDI codes on those devices.
An article from Securing Industry cites to the the Dutch Ministry of Health as saying that the decision to use the FDA’s UDI system was made to avoid adding complexity for manufacturers by requiring a separate system. According to the article, the Netherlands is the first in the EU to adopt the FDA’s UDI system, a decision that some believe may increase the chances of the UDI system being adopted elsewhere in the region.
In 2013, the US published the rule requiring UDI codes to be assigned by device manufacturers to each version or model of a device. Under the published rule, the codes must be in both human and machine readable formats. According to the FDA, implementation of UDI codes improves patient safety, modernizes device postmarket surveillance, and facilitates medical device innovation.
FTC Approves Tornier and Wright Medical Merger
The U.S. Federal Trade Commission (FTC) recently issued a final order that conditionally approves the merger between Amsterdam, Netherlands-based Tornier N.V. and Memphis, Tennessee-based Wright Medical Group, Inc. Reuters reports that the all-stock transaction is valued at about $3.3 billion. Plans for the merger were first announced in October 2014, and approved by the shareholders of both companies in June 2015, subject to receipt of clearance by the FTC. Progress on the transaction was suspended when the FTC expressed concerns that the merger would reduce competition for total ankle replacements and total silicone rubber (silastic) toe replacements in the U.S. market.
The FTC’s Bureau of Competition enforces U.S. antitrust laws and works with the Bureau of Economics to investigate alleged anticompetitive business practices. On occasion, the Bureau urges the Commission to take law enforcement action. In this case, the FTC’s concerns were the final obstacle to the proposed merger. The recent final order, which follows a mandatory public comment period, settles the FTC’s allegations of anticompetitive behavior.
The order calls for Tornier to sell a portion of its U.S. assets and IP rights to Integra Lifesciences Corporation (NASDAQ: IART), a competitor in the U.S. orthopedics space, which is based in Plainsboro, New Jersey. The newly combined company will be required to provide Integra with ankle and toe replacement products for up to three years. Through this arrangement, the FTC seeks to foster competition in the affected market.
In addition to its upper and lower extremity portfolio, the merged companies will maintain a presence in the growing biologics market. Wright Medical recently obtained FDA approval on the Augment bone graft material (left), which is as an alternative to autograft in a variety of arthrodesis procedures. Tornier has developed a line of biologics that includes its BioFiber line of absorbable scaffolds and its Conexa reconstructive tissue matrix, both of which are used for soft tissue repair.
The U.S. market for cell-based therapies for musculoskeletal injuries (orthobiologics) is valued at over $1.5 billion and is expected to grow significantly in 2016. Other market participants in the orthobiologics space include Dublin, Ireland-based Medtronic (NYSE: MDT), San Diego, California-based NuVasive (NASDAQ: NUVA), Kalamazoo, Michigan-based Stryker (NYSE: SYK), and Johnson and Johnson’s West Chester, Pennsylvania-based DePuy Synthes (NYSE: JNJ). Orthobiologics are part of the growing field of regenerative medicine, which includes bioprinting and stem-cell based therapies, and is projected to be worth $6.5 billion in the U.S. by 2019. Bioprinting, itself, has received recent investment and growth.
Following the merger, the resulting company will be renamed Wright Medical Group, N.V. and will be incorporated and headquartered in the Netherlands.
OrbusNeich Sues Boston Scientific In Ireland
OrbusNeich Medical Inc. and its subsidiary, Orbus International B.V., announced on Friday a lawsuit against Boston Scientific Corp. in Ireland for alleged patent infringement. According to the press release, the lawsuit alleges that Boston Scientific’s coronary stent systems, including the PROMUS Element™, PROMUS Element Plus™, OMEGA™, TAXUS™, SYNERGY™, and Promus PREMIER™ lines of stents, infringe European Patent No. 2,311,412 and European Patent No. 1,341,482, both entitled “Stent having helical elements,” granted on August 9, 2012 and September 23, 2010, respectively. Figure 11 from the ‘412 patent is shown below:
In February, OrbusNeich filed suit against Boston Scientific for patent infringement in Germany and the Netherlands. A patent infringement suit filed by OrbusNeich against Boston Scientific in the U.S. in 2009 was stayed pending reexamination of the patents by the U.S. Patent and Trademark Office. The asserted European patents are available at EP 2,311,412 and EP 1,341,482.
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