Manufacturas Solco is a leading Mexican manufacturer of medical implants that are used predominantly in the spine. OXPEKK®-IG has been approved by the Mexican regulatory entity COFEPRIS in a range of spinal implants including the “DENNIA OXPEKK®-IG” cervical fusion cage, the “WASPP OXPEKK®-IG” and “ADDER OXPEKK®-IG” lumbar fusion cages, the “LIXUS OXPEKK®-IG” interspinous process spacer, a dynamic pedicle rod called “PEARLROD OXPEKK®-IG”, the “MOBULA OXPEKK®-IG”, a total cervical disc replacement, as well as the lumbar and cervical corporectomy implants “LIBELLULA OXPEKK®-IG”.
In order to gain approval OPM and Manufacturas Solco have worked together on a development that involved extensive use of OPM’s considerable biocompatibility file that it provides to its customers. Development and design of the implants were made in cooperation with the surgeons from the Department of Spine Surgery of the Instituto Nacional de Rehabilitación (INR), which is the premiere Mexican authority in spine. In addition Manufacturas Solco undertook extensive clinical studies which were published in the Revista del Hospital Juárez de México.
“Gaining regulatory approvals is by definition a long term process that requires considerable investment and a diverse set of skills,” said Scott DeFelice, President and CEO of OPM. “Manufacturas Solco has been a perfect partner who strongly committed to the process and made the necessary investment to realize this important clearance. We are very pleased that Manufacturas Solco and OPM can now benefit from the commercial success that this clearance will bring.”
“Manufacturas Solco set out to identify the leading implantable polymer technology and business partner for spinal implants. With OPM we were able to find both elements. We are now pleased that the multiple product lines which have been developed with OXPEKK®-IG are moving quickly to the commercial phase and we look forward to capitalizing on the many market transforming technologies OPM has to offer,” said José Manuel Soldevila, President of Manufacturas Solco.
This latest COFEPRIS clearance is in addition to substantial previous clearances of implantable devices manufactured with OXPEKK®-IG. Previous clearances include US FDA, Korean FDA, ANVISA Brazil and CE marks which cover a great spectrum of the orthopedic marketplace. OPM’s regulatory focus will now increasingly turn towards Japan and emerging markets.
OPM’s OXPEKK®-IG product is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The product is polyetherketoneketone (PEKK) and is within the class of polyaryletherketone polymers (PAEK). OXPEKK®-IG has been extensively implanted worldwide. The product is supported by comprehensive ISO 10993 biocompatibility and purity data. The biocompatibility data is available directly from OPM or in the firm’s extensive FDA masterfile, without any access fees. Given the long implantation history of OXPEKK-IG products, there are numerous clinically relevant studies on OXPEKK®-IG devices available for reference.
About Manufacturas Solco S.A. de C.V.Manufacturas Solco S.A. de C.V. was founded in Mexico City in 1969 by Jose Manuel Soldevila Resendiz as a part of the Zimmer Orthopaedic LTD group.In 1980 Manufacturas Solco transformed into a 100% Mexican company dedicated to the manufacture of orthopaedic implants, such as bone plates, screws, intramedular nails and Thompson stems.Around 1975, and together with Dr. Eduardo Luque Reboyar Manufacturas Solco started to develop some spinal device concepts, including the now famous Luque bar for scoliosis treatment. Manufacturas Solco also started manufacturing a complete lumbar spine system for Dr. Eduardo Luque Reboyar and, thereafter dedicated substantial efforts to the design and manufacture of spinal implants.Manufacturas Solco sells within the entire Mexican territory and exports to Guatemala, El Salvador, Nicaragua, Ecuador, Dominican Republic and Cuba.Since 2001 Manufacturas Solco is ISO 9001 certified and in 2010 obtained their EAR Certificate from Obelis and was granted with the certificationof Good Manufacturing Practices by the MexicanMinistry of Health.Manufacturas Solco S.A de C.V. is a leading Mexican company that develops and manufactures new spine systems with orthopedic doctors and neurosurgeons, always aiming to be amongst the best and most innovative in their field.For additional information, please visitand .
About Oxford Performance Materials, Inc. (OPM)Founded in March 2000, OPM has rapidly become an industry leader in the ultra-high performance thermoplastic polymers market. The firm’s versatile OXPEKK® polymers are currently being used in medical, space and defense, semiconductor and industrial markets worldwide. OPM is ISO 9001:2000 and ISO 13485:2003 certified.In February 2009 OPM was partially acquired by France’s leading chemicals producer, Arkema.For additional information, please visitor .
About ArkemaA global chemical company and France’s leading chemicals producer, Arkema consists of three strategically related businesses: Vinyl Products, Industrial Chemicals, and Performance Products. Arkema reported sales of 4.4 billion euros in 2009. Arkema has 13,800 employees across 40 countries and six research centers located in France, the United States and Japan. With internationally recognized brands, Arkema holds leadership positions in its principal markets.
For additional information, please visit .
OXPEKK® is a registered trademark of Oxford Performance Materials, Inc.
A Brink's security employee placed three sacks of cash containing a total 1.2 million euros in the hold of the Air Antilles plane before it headed from the French island of Guadeloupe to the Franco-Dutch island of Saint Martin.
The security guard took his seat on the ATR-42 turboprop plane but when the flight landed 40 minutes later it was discovered that 172,000 euros (238,000 dollars) were missing from the sacks.
Police are seeking a man who complained he felt ill and spent most of the journey in the toilet. In fact, he was removing panels to gain access to the hold in the rear of the plane.
Shortly before landing, the unnamed man -- who was travelling with a woman who appeared concerned about his health -- asked a hostess for an ambulance to meet him on the tarmac, witnesses said.
When the ambulance arrived, the man said he felt suddently better and walked out of the airport without having to go through the normal security checks and disappeared, police said.
"The ripple effect nationwide will be to galvanize supporters of marriage," said staff counsel Jim Campbell of Alliance Defense Fund, a conservative legal group.
On the federal level, opponents of same-sex marriage urged Republican leaders in the House of Representatives to intervene on their own to defend the 1996 Defense of Marriage Act, or DOMA, against pending court challenges.
"The president has thrown down the gauntlet, challenging Congress," said Tony Perkins of the Family Research Council. "It is incumbent upon the Republican leadership to respond by intervening to defend DOMA, or they will become complicit in the president's neglect of duty."
Conservatives also said they would now expect the eventual 2012 GOP presidential nominee to highlight the marriage debate as part of a challenge to Obama, putting the issue on equal footing with the economy.
Gay rights activists welcomed Wednesday's announcement from the Justice Department, sensing that it would bolster the prospects for same-sex marriage in the courts. Among Democrats in Congress, there was praise for Obama's decision and talk of proposing legislation to repeal the law altogether.
"I opposed the Defense of Marriage Act in 1996. It was the wrong law then; it is the wrong law now," said Sen. Diane Feinstein, D-Calif. "My own belief is that when two people love each other and enter the contract of marriage, the federal government should honor that."
On the state level, there were swift repercussions.
In Rhode Island, the Roman Catholic bishop of Providence, Thomas Tobin, said Thursday that his diocese would "redouble its efforts' to defeat a pending same-sex marriage bill in response to the announcement. In Iowa, conservative activist Bob Vander Plaats said the DOMA decision would invigorate a campaign to repeal the state's court-ordered same-sex marriage law.
"This gives us more credibility than ever with this issue," said Vander Plaats, who wants to topple the Democratic leadership in the state Senate that is blocking efforts to put a same-sex marriage repeal proposal on the ballot.
In Maryland, meanwhile, the state Senate was debating a bill that would make that state the sixth to legalize same-sex marriage — joining Iowa, Massachusetts, Connecticut, Vermont and New Hampshire.
Linsey Pecikonis of the gay-rights group Equality Maryland predicted the DOMA announcement would improve the bill's prospects.
"It's a recognition that government is no longer able to defend discrimination," she said.
In Congress, GOP House leaders gave no immediate indication whether they would intervene to defend DOMA in the ongoing lawsuits, but they harshly criticized Obama's decision.
"This is the real politicization of the Justice Department — when the personal views of the president override the government's duty to defend the law of the land," said House Judiciary Chairman Lamar Smith, R-Texas. "It's disappointing that the Obama administration continues to place politics above the will of the American people."
In fact, many polls show the public almost evenly divided on legalizing same-sex marriage, one reason the issue is so volatile politically.
Perkins, the Family Research Council leader, suggested that House Republicans would risk alienating their conservative base if they did not tackle the marriage issue head-on.
"The president was kind of tossing this cultural grenade into the Republican camp," he said.
"If they ignore this, it becomes an issue that will lead to some very troubling outcomes for Republicans."
Jon Davidson, legal director of the gay-rights group Lambda Legal, predicted the DOMA announcement would energize opponents of gay marriage, but he questioned whether that would have much impact on the 2012 presidential race.
"I think they will try to turn this into a major election issue," he said. "But the people who feel strongly that same-sex couples should not be allowed to marry were not going to vote for President Obama anyway."
Conversely, he said the gay community will rally behind Obama all the more eagerly.
"It's hard to imagine that with the repeal of `don't ask, don't tell' (enabling gays to serve openly in the military) and this decision, there will be anything less than enthusiastic support," he said.
Though the DOMA announcement elated gays and infuriated many conservatives, it did not do away with the law, which bars the federal government from recognizing gay marriages and allows states to deny recognition of same-sex unions performed elsewhere. Among its many effects, it forces same-sex married couples to file separate U.S. tax returns, and bars the transfer of Social Security benefits to a surviving same-sex spouse.
In California, where the fate of the state's same-sex marriage ban is in the hands of a federal appeals court, gay rights advocates welcomed the administration's action as validation of their plan to get the U.S. Supreme Court to consider the gay marriage issue. While the California case does not hinge on DOMA, lawyers for two couples suing to overturn Proposition 8 are relying on many of the same constitutional arguments made by the Justice Department.
One of the lawyers, Ted Olson, said the federal government's stance bolsters the positions taken by former Gov. Arnold Schwarzenegger and Gov. Jerry Brown in his previous role as attorney general when they decided not to defend Proposition 8. The net effect, he said, "will be very persuasive" as judges weigh the case.
California is among 30 states which have passed constitutional amendments aimed at prohibiting same-sex marriage.
Brian Brown, president of the conservative National Organization for Marriage, predicted that Obama's decision not to defend the federal DOMA would spur efforts in some of the remaining states to join the ranks of those with constitutional bans.
Indiana lawmakers took a step in that direction last week, and Brown said it was possible that amendments could gain traction in Wyoming, Minnesota, North Carolina and even New Hampshire, if GOP lawmakers succeed in repealing the state's same-sex marriage law.
"This raises the stakes and makes clear the executive branch is not willing to carry out its responsibility," Brown said. "I don't think by any stretch of the imagination the tables have turned on this issue. People in this country know what marriage is."
When DOMA was passed in 1996, an election year, it had broad bipartisan support. Over recent years, Obama has criticized the federal law without fully supporting gay marriage. White House spokesman Jay Carney said this week that the president was "grappling" with the issue but had always personally opposed DOMA as "unnecessary and unfair."
The Williams Institute, a think tank at the UCLA School of Law, estimates that about 80,000 legally married same-sex couples live in the U.S., including roughly 30,000 who wed in Canada or other foreign countries. An estimated 85,000 same-sex couples have entered civil unions or domestic partnerships, the institute says.