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Covidien has bolstered its medical device portfolio by agreeing to buy Langhorne, PA–based Power Medical Interventions Inc. (PMI). PMI is a provider of computer-assisted, power-actuated surgical cutting and stapling products. It has recently introduced to the medical market wireless surgical instruments with minimally invasive surgery applications.

According to Covidien, it will “pay $2.08 in cash per share of PMI common stock. Aggregate consideration, including assumption of debt, will total approximately $64 million.”

PMI’s CEO says about the acquision, “We are excited to join Covidien’s Surgical Devices business unit and look forward to establishing a technology platform that will advance surgical stapling and instrumentation beyond the capabilities of existing manually operated devices.”

Senator Charles Grassley (R–IA) appears to be pretty familiar with medical device regulatory issues and not afraid to ask the tough questions. That’s why it should come as no surprise that he’s once again investigating some potential ethical no-nos surrounding device firms and conflicts of interest. This time the target is David Polly, a prominent spine surgeon who was a consultant for Medtronic—and received about $1.2 million for his services during a four-year period (2003–2007).

In a July 24 letter, the senator asks the University of Minnesota, which employs Polly as the head of the spine service unit of the school’s Department of Orthopedic Surgery, how it monitors potential conflicts of interest involving medical school doctors that moonlight as consultants for medical device companies.

The 142-page letter also accuses Polly of testifying before a Senate committee without disclosing that he was being paid by Medtronic. Grassley goes on to charge that Polly told Medtronic about the progress of government-sponsored research, which violates an agreement with the university, and that Polly may have given inaccurate information to a university ethics committee.

Earlier this year, it was announced that the Department of Justice had subpoenaed Medtronic to find out more about its relationship with another one of its consultants, Timothy Kuklo.

Medtronic and Abbott have agreed not to sue each other over stent technology, thanks to Medtronic’s offer to pay $400 million to Abbott. The settlement resolves all outstanding intellectual property litigation between the two medical device makers, who agreed not to sue each other again in the area of coronary stent and stent delivery systems for at least 10 years. Medtronic said it will also pay $42 million to evYsio Medical Devices as part of a sublicense to Abbott of evYsio’s stent design. Medtronic expects to report a special charge against its first-quarter financial results for the settlement with Abbott.

Obama’s drive to overhaul the nation’s healthcare system could force the device industry to make some sacrifices. Analysts speculate that a $15–25 billion deal to reduce healthcare costs could be reached between the government and the device industry, says Dow Jones.

But Larry Biegelsen, a Wells Fargo analyst, says that a deal above $15 billion won’t please investors. “We believe any deal the industry agrees to will be viewed as a net negative for investors, as few expected healthcare reform to have a direct impact on medical devices,” Biegelsen wrote in a note to investors, according to Dow Jones.

The White House is staying quiet on the subject, and AdvaMed hasn’t acknowledged whether a deal is being negotiated. However, Biegelsen says an agreement could come in September. The government has already reached an $80 billion deal with the pharmaceutical industry.

Remember last month when several congressmen introduced a bill that would create a registry for artificial knees and hips? Another registry proposal has surfaced, this time contained in America’s Affordable Health Choices Act of 2009. But this one is more comprehensive and, according to AdvaMed, problematic. This new registry would list medical devices by type, model, and serial number. The goal is to help HHS monitor postmarket safety and effectiveness of all Class III devices and certain Class II devices.

AdvaMed says that in its proposed form, the registry might include “every staple and every suture” in addition to thousands of devices such as defibrillators and stents. AdvaMed CEO Stephen Ubl said that data from such a registry would be “too broad” and “redundant with existing FDA postmarket authorities and initiatives.” AdvaMed’s vice president of technology and regulatory affairs, Tara Federici, said that meeting data requirements for the registry would be burdensome, often for financial reasons. It would be “expensive for the manufacturer, expensive for the hospital and for the provider, assuming they get around to filling in this data.”

Global Industry Analysts (GIA) has released reports on sectors in the medical industry. Here are the predictions the firm has made for several device segments.

Cardiac Rhythm Management Devices:  $26.2 Billion by 2015
Drivers: The rise of the aging population and cardiac abnormalities
Products: Pacemakers, internal cardiac defibrillators (ICDs), external defibrillators, and associated devices represent the largest segment of the cardiovascular devices market.
Emphasis: Product safety and technological development.
Market Leaders: Boston Scientific, Bard Electrophysiology, and Medtronic Inc.

Gastrointestinal (GI) Endoscopy Devices Market: $2.52 Billion by 2015
Drivers: A rapidly aging population and increasing incidences of GI disease have made the endoscopes the most utilized diagnostic tool.
Products: Growth is expected to occur in the area of techniques such as robotics, miniaturization and imaging, moving away from GI videoscopes.
Emphasis: A prevention screening market will also contribute to growth.
Market Leaders: Boston Scientific, CONMED Corp., Fujifilm, and Johnson & Johnson.

Infusion Pumps Market: $6.8 Billion by 2015
Drivers: This market has been characterized by competition and cost containment efforts bearing from Group Purchasing Organizations; however, changing demographics, increased spending in healthcare and innovations in treatment have affected the market. The U.S. and Europe dominate this market.
Products: Strong opportunities are present in the homecare sector, particularly with the development of chemotherapy drugs and equipment upgrades with more cost effective devices. The increasing incidence of diabetes worldwide, as well as other lifestyle factors, may contribute to market growth.
Market Leaders: Animas Corp., Hospira Inc., Insulet Corp., and Smiths Medical.

Carbon Dioxide Monitors: $294 Million by 2015
Drivers: The requirement for enhanced patient monitoring will drive this market, especially outside of operating rooms.
Products: Emerging applications include critical care units, recovery rooms and post-anesthesia care units.
Market Leaders:  B. Braun Melsungen AG, Datascope Patient Monitoring, Drager Medical AG & Co KG, and GE Healthcare Life Support Solutions.

Mechanical Ventilators Market: $1.18 Billion by 2012
Drivers: Factors affecting growth in this market include the demand for new low-cost ventilators to replace equipment in mature markets. Emerging areas of Latin America and Asia-Pacific lead the way for growth though the U.S. remains the largest market.
Products: The fastest growing segment is projected to be portable ventilators.
Market Leaders: Companies leading the marketplace are Maquet, Covidien, Philips Respironics, and Spacelabs Healthcare.

Nanomedicine Market to Pass $160 Billion by 2015
Drivers: The unique properties of nanoparticles and their ability to be used in the course of disease diagnosis and treatment offer a robust opportunity in this market.
Products: The nanomedicine segment includes nanodrug delivery, nanoanalytical contrast reagents, nanobiomaterials and nanopharmaceuticals.
Market Leaders: The market is fragmented but several key players are Abraxis BioScience Inc.; Crucell N.V.; Elan Corp. Plc; Nanosphere Inc. and Wyeth Pharmaceuticals.

Doctors who are looking for treatment options for advanced macular degeneration will most likely soon have a device to help their patients. A pea-sized telescope, developed by VisionCare Ophthalmic Technologies (Saratoga, CA), is implanted into one eye to help improve visual acuity–especially in reading and facial recognition. The other eye, which has no implant, is then used for peripheral vision. However, not every patient with age-related advanced macular degeneration is a candidate for the Implantable Miniature Telescope (IMT). According to one retinal specialist who has authored papers on the IMT, only about 20 out of 100 potential candidates will receive the device. Reasons for ruling patients out include eye shape and balance issues.

The device has been approved in Europe, and VisionCare expects FDA approval later this year. In March, an FDA advisory panel unanimously recommended approving the implant.

Israel-based Elcam Medical has gained a U.S. manufacturing base by acquiring a majority interest in Injectech LLC (Loveland, CO). Injetech provides luer connections, barbed fittings, check valves, and custom injection molded components to the medical device industry. It also offers services from prototype to production runs.

Elcam Medical CEO Ehud Raiviitz says about the transaction, “We see great synergy between the two companies and their products. We are impressed with Injectech’s reputation among their customer base, especially their quality and responsiveness.”

Elcam Medical supplies fluid management, drug delivery, and vital signs monitoring systems and devices. It has expertise in high-volume precision molding, high-speed assembly, and laser applications.

The Los Angeles Times wrote today about Jeffrey Cadeddu, MD, from the University of Texas Southwestern Medical Center. The doctor saw a television program about magnets to hold studs to teenagers lips as an alternative to a more-permanent piercing. The trend inspired him to explore using magnets on surgical tools for minimally invasive procedures.

Last week, reports the Times, UT Southwestern announced it was teaming with Ethicon Endo-Surgery Inc. to develop a toolbox of magnetically controlled surgical instruments. The magnetic tools are expected to give surgeons greater maneuverability. Magnets outside the body would attract magnets attached to the instruments inside the body.

Northeastern University researchers have developed a cancer screening technology that analyzes a cell (and produces results) for cancer in seconds. By capturing the fingerprint of a cell’s biochemical composition, spectral cytopathology (SCP) can screen for oral, cervical, head, and neck cancers when the disease is in its early stages. It’s also possible that the SCP could have more than 95% accuracy versus the current screening method rate of 65 to 70% accuracy.

Once the SCP captures a cell sample, an infrared light probes the cell and its molecular component to generate a fingerprint. A computer analyzes the data and determines whether the cells are normal, precancerous, or cancerous. Max Diem, head of Northeastern’s lab for spectral diagnosis, anticipates that the SCP technology could be ready for application in no more than five years.