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Yesterday, FDA said it had been pressured by former agency commissioner Andrew von Eschenbach and four NJ lawmakers to approve a pad used to repair a torn or damaged meniscus. The agency stated in a report that following “extreme” and “unusual” pressure placed by NJ Democratic Senators Frank Lautenberg and Robert Menendez, along with Representatives Frank Pallone Jr. and Steven Rothman, FDA overruled scientists and approved Menaflex. The New York Times reports that these lawmakers made inquiries within months of receiving campaign contributions from ReGen Biologics Inc. (Hackensack, NJ), the manufacturer of Menaflex. FDA deputy commissioner Joshua Sharfstein questioned the agency’s integrity during the decision-making process. However, he said that patients who received the device shouldn’t panic and should instead await FDA’s review of the Menaflex approval.

Earlier this year, FDA was criticized for approving the device.

In an announcement made this morning, Integra Spine, part of Integra LifeSciences (Plainsboro, NJ), has bought Innovative Spinal Technologies Inc. (IST; Mansfield, MA) for $9.25 million. IST filed for Chapter 7 bankruptcy protection in May. According to a release issued by Integra LifeSciences, the acquisition was the result of an auction conducted by the Chapter 7 trustee. The company will reveal more details about how the purchase of IST will affect its finances during a Q3 earnings call in November.

IST manufactured spinal implants focused on minimally invasive surgery and motion preservation techniques. Integra plans on launching IST’s Paramount MIS/open system for percutaneous lumbar fusion procedures in Q1 2010. Other IST products include the Cordant cervical anterior planting system and the Axient line for posterior dynamic stabilization. Integra Spine acquired the IST portfolio of more than 100 U.S. and foreign patents and patent applications, along with trademarks and patent license agreements.

–From DeviceTalk

FDA given its stamp of approval on the first product specifically designed for suturing dural tears in spine procedures. Covidien’s DuraSeal spine sealant aims to work faster than traditional sealing methods; it takes two minutes to prepare for use and just three seconds to set. In a U.S. study, DuraSeal achieved an intraoperative watertight seal in 100% of cases, while more common sealing methods reached a watertight seal 64% of the time. FDA approved the same formulation, which is on the market for cranial procedures, in 2005. Covidien plans on launching the spine sealant within the next few weeks.

UK-based Surgical Innovations Ltd. (Leeds, England) has debuted its new flexible laparoscopic device at the International Federation for the Surgery of Obesity and Metabolic Disorders. Logi Flex is designed for gastric banding. Its flexible tip allows easy insertion of the instrument through the gastric tunnel. Its slot design enables the surgeon to have a positive grip on the suture, which allows the band to be pulled into position. The company is promoting the device as having the cost effectiveness of a reusable instrument while providing the optimum performance of a disposable device.

Patients suffering from multiple fractures upon arrival to the ER should only undergo a few hours of surgery if they’re in unstable condition. Limiting time in the operating room for patients with life-threatening injuries will help reduce the amount of blood loss during surgery and could lead to fewer complications. According to an article published in the Journal of the American Academy of Orthopedic Surgeons, this method of “damage control” helps to improve patient survival rates.

The doctors involved in the study examined outcome data from trauma patient registries in Germany and made a couple of conclusion related to patients with life-threatening injuries:

1. Use an external fixator to stabilize orthopedic injuries. This will stop initial pain and bleeding
2. Once the patient has stabilized (two or three days following initial surgery), this could be a more appropriate time to proceed with more invasive surgery.

Conducting fracture-repair surgery over several days allows the patient to recover from each procedure before moving ahead. This is critical, because a patient is more fragile after blood loss due to a potentially weakened immune system.

According to a recent market research report, cardiovascular biomaterials are expected to be the dominant segment of the biomaterials market in 2014, with a worth of about $20.7 billion. The report, by Markets and Markets (Wilmington, DE), projects the U.S. market, which is the largest geographical segment for biomaterials, to be worth $58.1 billion by 2014. From 2009 to 2014, this segment is expected to have a 15% compound annual growth rate to reach a worth of $22.8 billion by 2014.

The report cited metals and ceramics as the current dominating materials, while polymers are anticipated to spur the next wave of growth for biomaterials. According to estimates, nearly 100,000 heart valves, 200,000 pacemakers, and 1 million orthopedic devices are implanted annually. As this market grows, so does the demand for biomaterials–from 8% to 15%.

Last year, the largest biomaterials segment was orthopedics, which was worth $9.8 billion. However, the cardiovascular market is expected to surpass all segments, as it is estimated to experience a 12.5% compound annual growth rate from 2009 to 2014. The report is attributing the strong growth in the cardiovascular biomaterials market to more stress, which is raising the rate of cardiac arrest.

The factors of aging baby boomers and rising obesity and diabetes rates are combining to create the perfect storm for peripheral arterial disease (PAD). Not only is the disease underdiagnosed, but it’s poised to become a big problem for society as well as a huge clinical issue for literally tens of millions of patients, according to Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division.

According to statistics from recent studies, PAD affects an estimated 27 million people in Europe and North America—including 8 to 12 million Americans. With these numbers in mind, a new first-to-market drug-eluting stent (DES) is positioned to take advantage of a huge market opportunity in Europe.

Zilver PTX, manufactured by Cook Medical (Bloomington, IN), is the world’s first self-expanding DES for the superficial femoral artery (SFA). The device recently received a CE mark following the world’s largest clinical trial (1200 patients) for a peripheral stent. The Zilver stent is currently an investigational device in the United States.

The stent uses nitinol technology, which gives the device malleable properties before it’s implanted in the body. Once deployed, the stent stiffens up as it reaches body temperature. However, the advantage of nitinol is that if the device somehow becomes compressed, it immediately springs back to its original shape.

“What’s exciting about Zilver PTX, [is that] now [patients] have a brand new option—a drug-eluting stent,” says Lyles. “It’s a game changer—it puts an option into the mix that’s never been there.” Other treatment options for patients with PAD include balloon angioplasty, bare-metal stenting, and medical therapy, which doesn’t involve surgery. According to Lyles, balloon angioplasty has a 30% to 40% success rate in Europe. After two years, Zilver PTX demonstrated effectiveness in 90% to 95% of the cases.

“We’re going to be able to have a tremendous advantage in the market for a period of time, because it’s such a huge step, we have the data to back it up, and nobody else has anything that’s even close,” says Lyles. “From a competitive perspective, I think Cook is sitting in a very good spot relative to stenting the SFA.”

Zilver PTX is now available in nearly 50 countries worldwide, including Germany, France, Italy, Spain, the United Kingdom, and Israel.

Results of a new clinical study could bolster the market for implantable heart devices. Published in the September 1 edition of The New England Journal of Medicine, the study revealed that using cardiac-resynchronization therapy devices (CRTs) combined with implantable cardioverter defibrillators (ICDs) decreased the risk of heart failure events in certain patients. The findings also demonstrate the effectiveness of CRTs and ICDs in lowering the risk of heart-failure events in patents who are asymptomatic or mildly symptomatic. Coprincipal investigator David Cannom, MD, told the Boston Globe that the idea of the study is to implant CRT—ICD combination in patients earlier—before their disease has progressed to advanced heart failure.

The four-year study involved patients who had congestive heart failure but only experienced mild cardiac symptoms. Patients who had the CRT—ICD combination implant experienced a 40% reduction in hospital admissions related to heart failure. This figure is compared to patients who only had an ICD implanted.

According to analysts, an approval for using the CRT—ICD combination for early intervention could boost the global implantable device market by hundreds of millions of dollars, because it has the potential to slow down the progression of a difficult-to-manage condition. The president of Boston Scientific’s cardiac rhythm management division, Fred Cohen, told the Globe that the company will be applying for the expanded indication of the combined device by the end of this year. He stated that an indication expansion will push growth in the U.S. defibrillator market by nearly $250 million during the next two to three years, and up to $400 to $500 million globally.

The research was supported with a grant from Boston Scientific to the University of Rochester.