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Implant manufacturer SpineSmith (Austin) is helping biomedical engineering seniors at the University of Texas learn about how devices are designed, engineered, and commercialized. The students are working with the company’s product engineers to move the ideas of spine surgeons into creating products that can be commercialized. SpineSmith is conducting R&D work involving regenerative medicine and is hoping that through its work with the students, they can collaborate to develop products that will help patients on a global level. SpineSmith develops implants and regenerative biologics that are used for surgical fixation and tissue regeneration of the spine. 

With more than 6000 people from the city working in the sector, Memphis is holding on to its position as the U.S.’ second largest orthopedic manufacturing center (Warsaw, IN is #1). Since 1999, employment in the city’s biomedical device sector has grown 50%–that’s more than four times the national growth rate. Companies with division or corporate headquarters in Memphis include Wright Medical Technologies, Smith & Nephew, Medtronic, Symmetry Medical, Nuvasive, and soon-to-open Doosan. The Korean company makes machines, ranging in price from $50,000 to $500,000 that manufacturers can use to produce precision metal parts for implants such as artificial hips or knees. Doosan’s grand opening in Memphis is scheduled for early December. In addition to displaying machines, the site will also house a training space where employees can learn how to use the machines. 

A study released yesterday found that drug-eluting stents (DES) beat out bare metal stents in lowering the risk of heart attacks and death in diabetic patients. It also lowered their chances of having repeat surgeries. This is good news for people with diabetes, because they generally have a higher risk of death and heart attacks than those who don’t have the disease.  Funded by the Massachusetts Department of Health, the study examined more than 5000 diabetics who had artery-clearing procedures followed by stent implantation between April 2003 and September 2004. After three years, the risk of death in patients with the DES was 17.5% versus 20.7% in those with bare metal stents. After two years, the risk of a heart attack and the need for repeat procedures was reduced by 3% and 5.4% respectively. According to Harvard cardiologist Elliot Antman, MD, the results, revealed at an American Heart Association meeting, provide more reassurance for diabetic patients regarding the safety of DES. 

Cook Medical is conducting the world’s first clinical trial of a drug-eluting stent (DES) with a specific agent that aims to silence a gene that causes restenosis.  The GTX cobalt chromium stent (already approved for sale in Europe) will be coated with AVI BioPharma’s antisense RNA therapeutics agent, AVI-5126, a compound that is released after stent implantation. The drug, which is licensed to Cook, targets a key regulatory gene that is involved in restenosis and silences it before the restenosis cascade effect can be triggered. The study is being conducted in Germany. About 90 patients could be enrolled in the study and will undergo clinical follow up at 30 days and then six months. Study endpoints include  binary restenosis, target lesion revascularization, and in-stent and in-segment late loss. Data will be compared to the historical controls of bare metal stents and DES. 

AtriCure Inc. (West Chester, OH) could have some hard times ahead. Lower procedure demand, combined with an investigation into the company’s marketing practices, has led AtriCure to withdraw its 2008 financial guidance. This might come as a surprise given that just this week the company reported record international revenues of $2.4 million (29% growth) and record domestic revenues of $5.7 million (63% growth) for its minimally invasive products. Aside from the third-quarter success, last week AtriCure announced that the Department of Justice is looking into  the company’s marketing practices related to its surgical ablation system for atrial fibrillation. It is also examining whether AtriCure told hospitals to bill Medicare for ablation using incorrect billing codes. President and CEO David Drachman said the company is unsure what effect this could have on business. He also expressed concern about the current economic state, which is lowering the growth of the company’s elective procedures. Unfortunately, these factors led AtriCure to lower expectations and withdraw its financial guidance for the remainder of the year. 

A recent study finds that males under 55 years of age are the best candidates for hip resurfacing.  After reviewing 537 U.S. surgeries involving Smith & Nephew’s Birmingham Hip Resurfacing implant, the research team observed that women of all ages and men older than 55 experienced most of the serious complications. Lead study author Craig Della Valle, MD, advises that older patients seek conventional hip replacement.  Among the serious complications, which occurred in 32 cases, 10 patients experienced a femoral neck fracture following surgery (this doesn’t usually happen with conventional hip replacements). The femoral neck is the area of bone just below the femur’s head.  Other serious complications included dislocated joints, nerve injury, deep infection, and fracture of the proximal femur.

The correlation between age, sex, and fractures could be due to the fact that both older people and females generally have softer bone. Males have larger bones and a greater surface area in which the implant can be secured, according to Della Valle.

The study was conducted by the Rush University Medical Center (Chicago).

Cardiovascular Systems Inc. (CSI; St. Paul) is going public via a merger with Colorado-based Replidyne Inc., an already publicly-traded company.  The deal will allow CSI to become profitable, because it should gain about $35 to $40 million in cash and investments from the merger. The newly merged company will also apply for a new trading symbol on the Nasdaq exchange. CSI filed for an initial public offering in January, but due to poor market conditions, the company believes the merger will provide a better opportunity for growth.

CSI develops interventional devices for treating vascular disease. Its first product, the Diamondback 360° treats plaque above and below the knee using a minimally invasive catheter system. CSI’s main competitors include Ev3 and Spectranetics. Replidyne is a biopharmaceutical company that develops anti-infective products. 

While some of the hype surrounding gender-specific implants has died down, companies are still quick to point out how their products are appropriate for both sexes. A total knee system from Cardo Medical (Los Angeles) recently received FDA clearance, and the company’s VP of R&D, John Kuczynski, says that its femoral component can not only accommodate the anatomy of males and females, but since it doesn’t require gender-specific components, it provides huge savings for operating rooms. The product, called the Align 360 Total Knee System, is planned for launch in next year’s second quarter. Cardo Medical now has three systems designed for the knee. The other two are the unicompartmental system and the patello-femoral system, both for treating degenerative knee conditions.