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Cardiovascular products should do better than other technologies in the medical device industry, according to Frost & Sullivan Industry Analyst Venkat Rajan. In an article titled, The Cardio Market: Recession Resilient?, Rajan discusses the current market and areas of growth, like transcatheter valves. He says that companies will be looking to the cardio market for its long-term opportunities and potential “buy bargains.” With a more risk-averse climate, investors will be more interested in products with lower risk, technologies that have a faster return on investment, and products that involve a less stringent approval process. For more of Rajan’s insights, check out his article online.

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Robotic-assisted laparoscopic surgery (RALS) could result in more effective suturing and faster procedure times compared to freehand laparoscopy, even among inexperienced surgeons. According to a recent study published in the April issue of the Journal of the American College of Surgeons, RALS has a flatter learning curve than freehand laparoscopy, despite how different a surgeon’s familiarity may be with laparoscopic methods.

“Our findings show that, over a relatively short time, even inexperienced surgeons can perform RALS with efficiency and results comparable to open surgery,” said Hiep Nguyen, MD, director of robotic surgery and research at Children’s Hospital Boston. “RALS is allowing us to perform suturing more quickly and safely, and we hope that ultimately this will allow for patients to recover faster and with reduced pain.”

Surgeons are able to effectively and precisely navigate the anatomy using RALS, because the robot provides full range of motion and 3-D visualization.

For years, doctors have been using certain devices in an off-label manner when treating children, because there aren’t enough devices approved specifically for this smaller population. One physician and his colleagues at the Heart Institute at Cincinnati Children’s Hospital Medical Center called attention to their study, which found a strong use of off-label applications in pediatric procedures performed at the center between 2005 and 2008. Their findings, recently presented at the American College of Cardiology’s annual meeting, highlight the lack of regulatory oversight to ensure the safety and efficacy of devices, according to Robert Beekman, MD, pediatric cardiologist at the center. “Children deserve to benefit from new and refined cardiac devices designed explicitly for their conditions,” he added.
The study found that the most common off-label applications involved stent implantations (99%) and balloon dilations (78%). Although many doctors feel that there aren’t an adequate amount of pediatric devices, the Cincinnati Children’s hospital has been addressing this need by developing technology for children. It has several devices available for commercialization, which can be viewed on the hospital’s Web site. Among the devices are a standard right angle cannula for cardiac surgery and an automated painless injection device. Companies that are interested in commercializing the pediatric devices should visit the hospital’s Center for Technology Commercialization online.

Since his arrival in 2003, ATS Medical (Plymouth, MN) President Michael Dale has helped push the company from one that was losing money into a diversified business that achieved a 33% rise in revenue last year. One year before Dale joined ATS, the company revenue had dropped to $13 million, with just 28 employees. In 2008, employee count reached 200 in Minnesota and more than 300 globally. Its share of the worldwide mechanical valve market rose 14% last year as well. Although Dale isn’t one to take credit for the comeback, he saw the company through a difficult contract dispute (it began before he started at ATS) and mobilized a strategy to diversify product line. The business strategy has added tissue heart valves, valve repair technology, and cryoablation products, and Dale believes this move will help push sales to more than $100 million.

-From DeviceTalk

A device developed by UK-based Activ4Life will help doctors monitor the activity levels of hip and knee replacements in patients for several months before and after surgery. The company plans on making the ProV3.8 system available in the United States next year and will be looking for distributors and partners in the country this year, according to a spokesperson.

The lightweight device also lets doctors monitor a patient’s level of pain. During the day, it can be worn underneath clothing. At night, it is rested on a docking station, and the patient records any pain experienced that day, on a scale of one to 10. The data is then transmitted from the docking station via a mobile phone network to a company server. From there, it is analyzed against an assigned activity profile based on the patient’s age, gender, body mass index, operative state, and activity levels. The collective information enables doctors to individualize treatment from rehabilitation routines to recovery predictions.

Millstone Medical Outsourcing (Fall River, MA) has expanded its Memphis facility to keep up with company growth. The additional 12,000 sq ft provides more space for advanced inspection, material storage, and distribution services. Millstone Medical, and an outsourcing partner with orthopedic companies, also plans on hiring more staff in as a result of the expansion, which brings the plant to about 43,600 sq ft.

Colorado-based Encision Inc. (Boulder) is extending its reach from conventional laparoscopy into robotic surgery. The company entered into a nonexclusive manufacturing agreement with Intuitive Surgical Inc., which has a virtual monopoly on surgical robotics. The agreement involves the purchasing and use of Encision’s active electrode monitoring (AEM) technology with Intuitive Surgical’s da Vinci systems.

Encision’s AEM laparoscopic instruments are designed to protect patients from burns that can result from insulation failure and capacitive coupling. The company’s President and CEO Jack Serino is optimistic about the partnership, which will move Encision into the “rapidly growing market segment of laparoscopic robotic surgery.”

The $4.2 billion acquisition of Kyphon by Medtronic has been a “bit of a disappointment,” according to Medtronic CEO Bill Hawkins. The deal, announced nearly two years ago, has hit a few bumps, including a management shakeup, a poor product launch, a DOJ settlement, and increased federal scrutiny. Some delays in combining Kyphon into Medtronic’s spine division have come from the unsuccessful (and premature) marketing of Kyphon’s X-Stop Spacer for lumbar spine stenosis. The product didn’t do well in the market and had to be relaunched after doctors had to undergo more training and education about the product’s patient population, according to CFO Gary Ellis. Other delays last year included the exit of Pete Wehrly, president of Medtronic’s spine division. He was replaced with Steve LaNeve, head of the company’s operations in Japan. The Star Tribune also reports that differences in product demographic and sales rep method caused problems as well. Medtronic’s spine division mostly marketed to younger patients with scoliosis and degenerative disc disease, while Kyphon focused on older patients who had spine fractures and stenosis. Aside from what could be perceived as a difference in sales method, Ellis says few people were lost in the merging of the sales force. And despite the slower-than-desired integration, the company has taken care of most of the issues with Kyphon, Ellis says.

With the recent launch of the first-of-its-kind wire guide cannulation system, Cook Medical isn’t just continuing its focus on minimally invasive technologies. The company’s endoscopy small business unit is pushing to have a significant effect on the global wire guide market for gastroenterology, which is valued at $175 million, estimates Barry Slowey, vice president of global sales and marketing at Cook Endoscopy. In the United States, this market is valued at about $75 million market and is growing about 8-9% percent a year.

The Fusion LoopTip gives doctors a flexible and minimally invasive way of gaining access to the tortuous anatomy known as the pancreato-biliary ductal system. Doctors need access to this area when treating or diagnosing gallstones, strictures, and other conditions. The wire guide comes in difference lengths and has a radiopaque coil spring for fluoroscopic visualization. This is a big improvement over past wire guides, says Slowey, which were stainless steel, and thus prone to kinking. The new wire guide has graduated from stainless steel to a nitinol core with a coating that prevents potential electrocution during cutting.

The flexible loop on the end of the wire guide (as opposed to a blunt tip) was the brainchild of a doctor from Chile who came to Cook Endoscopy with the idea nearly seven years ago. During one of the first stages of the human trials involving the device, the doctor was able to gain access to the biliary duct in 98% of the 300 patients.

Now with a full launch of the device, Slowey is expecting the wire guide to make its mark. “There’s a trend more and more to access the biliary system with a catheter or with a wire guide, but the trend is moving more and more to accessing it with a wire guide,” he says. “Our hope would be that this becomes the standard in wire guide cannulation.”

As a short-to-medium term goal, Slowey is hoping to get a 10% adoption rate worldwide, which would total $15 to $20 million of the market. He’s also realistic about the learning curve, since the device involves a new technique.

Cook Medical has been in the field of endoscopy for 25 years. “[We took] minimally invasive devices that were coming from radiology and urology and adapted them specifically for gastroenterology,” says Slowey.

Cook Endoscopy, the third largest small business unit of Cook Medical, differentiates itself from the competition by supplying a complete line of endoscopy products, from metal stents to dilation balloons and biliary devices, which could give the company an edge in today’s economy.

“What we’re seeing happening in the U.S. in particular is that individual hospitals, or more often, groups of hospitals, are looking for more [needs to be met] and are sophisticated about purchasing,” says Slowey. Many companies want to work one primary vendor to avoid the high costs of being involved with too many vendors. “[We have] a number of competitors, but they tend to focus on specific aspects or segment of the GI endoscopy market.”