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Spectranetics Is Target of Federal Probe

The investigation concerns the sales and marketing practices related to certain products, as well as payments made to medical personnel who took part in the firm's clinical studies. The feds are also seeking information on two postmarket studies conducted from 2002 to 2005 and payments made to personnel in connection with those studies, as well as on compensation packages for certain company employees. Spectranetics says it is cooperating with the investigation, and does not expect business to be disrupted.

Zimmer to Buy Abbott Spine for $360 Million

David Dvorak, Zimmer's CEO, said the acquisition will strengthen the company's sales scope, product pipeline, and add to its R&D capabilities.

Switches and Connectors

SPOTLIGHT

Switches and Connectors

Differential switches

An ultrasensitive line of RoHS-compliant miniature pressure, vacuum, and differential switches are used in such medical applications as oxygen-level monitors, sip-and-puff mobility control, and respiratory devices. The Designflex switch line is enhanced by a variety of housing, mounting, port, diaphragm, and set-point configurations. Designed to provide high durability and long life, the switches can withstand sterilization. Custom switch designs are also offered.
World Magnetics, Traverse City, MI
www.designflexswitches.com


Push-button switches

A series of sealed push-button switches includes a flat-top plunger switch that allows for customization, including customer-specific markings, backlit legends, custom-molded caps, and wire assemblies. The IPP series is suitable for medical equipment and any other application requiring a sealed ergonomic electrical interface. Available in versions offering momentary and maintained function, the switches come with a black bezel frame and a choice of seven actuator colors, and feature a reliable elastomeric seal. They are sealed to IP67. Manufactured with gold-plated silver contacts and supplied either prewired or with solder lug terminals, these push-button switches are rated for 100 mA and 200,000 cycles at 24 V dc and for 2 A and 10,000 cycles at 125 V ac.
Apem Components Inc., Haverhill, MA
www.apem.com


Panel-mount connectors

Featuring circular industrial connectors with a one-touch bayonet locking system and color-coded leads, a line of connectors has been expanded to include front and rear versions of the XS5M panel-mount plugs and XS5P panel-mount sockets. Smartclick connectors provide an audible and tactile click to indicate that a lock is secure. Designed to reduce assembly time associated with screw-style connectors, this line of connectors also can provide better seal performance compared with screw-style products because the potential for over- or under-tightening of a seal is eliminated. Equipment downtime can be reduced by the connectors’ shock- and vibration-resistant design and their secure locks.
Omron Electronic Components LLC, Schaumburg, IL
www.components.omron.com


Canted-coil spring contacts

Providing reliable electrical contact solutions, a company offers connectors featuring its canted-coil spring technology. The combination of the canted-coil spring and metal housing in the Bal Contact connector ensures constant electrical contact during lead-insertion processes for cardiac or neurostimulation applications. Using multiple contact points for increased conductivity, the connectors function at a low operating temperature and perform self-cleaning in dynamic or vibrating environments, which helps improve the connectors’ life cycle and durability. Each connector coil deflects independently to compensate for contact and surface variations. Several spring materials are offered; among them is platinum iridium, which provides corrosion and oxidation resistance suited for medical electronic applications.
Bal Seal Engineering Inc., Foothill Ranch, CA
www.balseal.com


Sensor control system connectors

A manufacturer offers a family of connectors and related products that provide durable, reliable, and easy field-termination interconnection for discrete wire applications commonly found in sensor control systems. The family includes Mini-Clamp II connectors, the Mini-Clamp II 371–series wire-mount plug, and the Mini-Clamp II 373–series wire-mount socket. The compact design of the RoHS-compliant wire-mount plugs helps save board space. The connectors feature integrated cable retention and can accept multiple wire diameters. The manufacturer also offers a die-cast version of its surface-mount mini-delta-ribbon 102–series right-angle receptacle, which can be used in patient-monitoring equipment and oximeters.
3M Interconnects, St. Paul, MN
www.3m.com/interconnects


Spring-probe connectors

Connectors featuring spring-probe technology are designed to enable high-density connections, shorten board-to-board heights, and simplify product design by eliminating mating counterparts. Providing continuity in high-shock and high-vibration environments, the connectors are suited for use in portable defibrillators, organ transplant systems, surgical tools, and MRI equipment. Featuring ingress protection and resistance to dust and chemicals, the connectors can perform in a range of temperatures. Contact-to-contact spacing is as small as 0.4 mm and signal paths can be as short as 2.4 mm. Connectors for blind mating are also offered.
Interconnect Devices Inc., Kansas City, KS
www.idinet.com


Interconnects

Expanding its line of board-to-board and cable-to-board products, a manufacturer offers a family of interconnects designed for applications where signal integrity and durability are critical. Edge Rate contacts provide impedance matching and high cycle life. They also can help reduce broadside coupling and crosstalk, according to the manufacturer. Board-level systems featuring these contacts include the ERM8 and ERF8 series of the contacts’ interconnect strip system and the high-speed RiseUp MicroCard stacking system. Also in the expanded product family, the Searay open-pin-field arrays and differential-pair arrays offer maximum grounding and routing flexibility.
Samtec Inc., New Albany, IN
www.samtec.com


Miniature connectors

Available in up to 65 contact configurations, tiny connectors use contacts that have a low mass and an engagement force of approximately 1 oz. The low mass of the size 30 Mite-Y-Pin contacts prevents interruptions in the NanoMiniature connectors’ shock and vibration modes. Because the connectors are used in such medical applications as drug delivery and invasive and noninvasive patient monitoring and imaging, the contacts are contained in a liquid-crystal polymer insulator, which is housed in a metal shell for maximum reliability. In addition to selecting from a variety of plating materials, customers can choose among aluminum, stainless steel, or titanium metal housings.
Ulti-Mate Connector Inc., Orange, CA
www.umi-c.com


Copyright ©2008 Medical Product Manufacturing News

Are Zaps to the Heart Actually Harmful?

The president of the Heart Rhythm Society, N.A. Mark Estes, MD, pointed out that the devices used in the study are much older than current devices that use pacing methods to correct abnormal heart rhythms before administering a shock. There's no denying that defibrillators can have a significant effect on extending life. Another study published in the same issue of the journal concluded that after 30 months of follow-up, the use of defibrillators didn't result in adverse quality of life issues in patients. Yesterday David Nexon, senior executive vice president of AdvaMed issued a statement in response to the study. âEURoeIt is important to put the results of the study within the context of the significant overall patient benefit of implantable-cardioverter defibrillators (ICDs)," said Nexon. "First and foremost, ICDs are incredibly successful in achieving their primary purpose: saving lives. ICDs are 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest. The SCD-HeFT data set used by the studyâEUR(TM)s authors showed that ICD therapy significantly reduced all-cause mortality by 23 percent compared to placebo, and ICDs were superior to drug therapy. Several other studies also have demonstrated the benefits of ICD therapy."

Helix Medical Expands Operations to Include Thermoplastic Molding

NEED TO KNOW

Helix Medical Expands Operations to Include Thermoplastic Molding

A series of acquisitions during the past several years has enabled contract manufacturer Helix Medical LLC (Carpinteria, CA; www.helixmedical.com) to broaden its offerings to the medical device market. Additional manufacturing facilities, along with thermoplastic injection molding services, are expected to complement the company’s current capabilities, which include liquid injection, compression, insert, and two-shot molding, as well as extrusion, assembly, packaging, and sterilization.

The acquisition of Apec (Baldwin Park, CA; www.apecplastics.com) earlier this year has equipped Helix to meet the thermoplastic injection molding needs of the industry. Apec’s operations comprise a 72,000-sq-ft facility in Southern California and a 35,000-sq-ft medical component manufacturing facility in Shenzhen, China. Equipment includes Arburg and Toyo presses ranging from 28 to 300 tn, and seven silicone liquid injection molding cells that enable the company to process both thermoplastics and silicones in the same Class 100,000 cleanroom.

Also a manufacturer of a proprietary brand of platinum-cured silicone tubing, Helix has further bolstered its silicone expertise in recent years through the purchase of a Gloucester, MA–based manufacturer specializing in silicone-based healthcare products. The company, formerly named Jenline Industries Ltd., became a division of Helix Medical in 2007 and was renamed Helix Medical–Gloucester Operations in 2008.

“We are well positioned to meet the needs of our customers with these additional manufacturing operations and continue our hallmark service offerings of extrusion and custom molding of platinum-cured silicone products for the medical device, healthcare, pharmaceutical, and biotech industries,” says Jorg Schneewind, CEO, Helix Medical.


Copyright ©2008 Medical Product Manufacturing News

ConvaTec Buys Danish Company

The firm will have four main divisions: ostomy care, wound therapeutics, continence and critical care, and infusion devices.

Cardinal Divests Itself of a Device Business after a Year

Medsystems, which will be renamed Corpak Medsystems Inc., makes enteral devices and airway management products. Cardinal said Medsystems did not fit into its future plans. Viasys, which Cardinal bought in June 2007 for $1.54 billion, was named as one of MD&DI's 50 Companies to Watch in 2006. It was recognized in part for its Cortrak feeding tube placement system, which won a Medical Design Excellence Award that year. That product is now in the portfolio of the new company.

Industry to Brainstorm About Hospital-Acquired Infections

That means that medical device companies who sell catheter-based products will have to be very careful about how they are designed. Leaders from the device industry and other stakeholders in the healthcare system will meet in October to discuss how to prevent line sepsis. Cook Group is one company that treats catheters with antibiotics to prevent line sepsis. (In Cook's case, the antibiotic is not coated on the catheter but embedded within it.) It will send representatives to the summit. What follows are the thoughts of Dr. Charles McIntosh, its vice president and chief medical science and technology officer, about the upcoming summit. He provided them exclusively to MD&DI. "Preventable medical errors that occur during or after hospitalization are estimated to cost about $1.5 billion a year, according the Agency for Healthcare Research and Quality. Beginning Oct. 1, 2008, CMS will no longer pay hospitals for several conditions deemed preventable when following evidence-based guidelines, including several hospital-acquired infections (HAIs) such as line sepsis and catheter-associated urinary-tract infections (UTIs). Recently, questions have been raised by the media and medical professionals about treatment for line sepsis and other HAIs. Such questions include the effectiveness of the treatment, as well as the validity of the research supporting the treatment. Despite the scrutiny, effective treatment options are necessary if and when an infection occurs. However, greater attention must be paid to preventing line sepsis. Line sepsis develops when bacteria enter a patientâEUR(TM)s bloodstream through a central venous catheter (CVC). CVCs are universally employed in the intensive care unit as key medical devices to deliver frequent and/or continuous injections of fluids and medications. But they inherently carry a substantial risk of infection, either from the device itself or from contaminated medical supplies. Of the estimated 1.7 million HAIs in the United States annually, the CDC estimates at least 250,000 of these cases are line sepsis. With an associated attributable mortality rate of 12-25%, this infection is the second-leading cause of death associated with HAIs, second only to pneumonia. Line sepsis can lead to acute respiratory-distress syndrome, kidney failure, shock and other potentially fatal ailments. Additional treatment costs for line sepsis average about $35,000 per infection. Clearly, preventing sepsis must be a major priority to protect patient lives and help corral rising health care costs. From the insertion of the CVC, to administering injections, to providing bedside care to a patient with a CVC, bacteria are often easily transmitted through improper hand hygiene at all levels of the healthcare system. In response, the CDC specifies that healthcare workers wash their hands before and after contact with each patient, change gloves when moving from a contaminated site to a clean site on the same patient and use full barrier sterile precautions when inserting devices such as CVCs. The CDC also recommends the use of chlorhexidine over betadine prep, as it has shown to be more effective in reducing infections. Investigators have found that process alone will not consistently eliminate the risk of infection, particularly in high-risk patients. Technology, however, can help close the gap. For example, a new generation of catheters impregnated with the antibiotics minocycline and rifampin has been proven to reduce the risk of CRBSI. In October, thought leaders from the nationâEUR(TM)s leading healthcare and quality organizations and hospitals, including the CDC, CMS, the Association for Professionals in Infection Control and Epidemiology, and Johns Hopkins University Hospital, will meet in Washington, DC to discuss the increased accountability regarding line sepsis. At the âEURoeLeadership Strategy for the Prevention of Line SepsisâEUR summit, the group will formulate standardized recommendations on how hospitals and medical practitioners can employ evidence-based process measures and technology to reduce the occurrence of line sepsis to as close to zero as possible. Healthcare professionals have always been committed to improving patient care, and so a solid commitment must be made to not just treating HAIs, such as line sepsis, but preventing them. Adherence to infection prevention best practices recommendations by the âEURoeLeadership Strategy for the Prevention of Line SepsisâEUR summit looks to be a major step in reducing the occurrence of preventable infections and providing patients with a safer hospital stay."

Programmed Peptides Help Drugs Cling to Devices

NEED TO KNOW

Programmed Peptides Help Drugs Cling to Devices
Stephanie Steward
Affinergy's interfacial biomaterials help drugs cling to the surface of medical devices, such as this hip implant, without altering their surfaces.

Biologically linking molecules while at Duke University (Durham, NC; www.duke.edu) led the founders of Affinergy Inc. (Durham, NC; www.affinergy.com) to develop what the company calls interfacial biomaterials (IFBMs). This peptide technology helps drugs and biologics cling to medical devices without altering their surfaces, and could potentially reduce health complications.

“Peptides are nanoscale coatings which do not appreciably alter the surface of the medical device,” explains Affinergy CEO Peyton Anderson. “For example, stainless steel will still act like stainless steel with our coatings even though a drug has been added. We can tether the biologic to a surface but not inactivate or change the therapeutic effect of the biologic.” The peptides bind to almost all traditional device materials, and the company is expanding the number of therapeutics that the IFBMs can bind to device surfaces.

The company likens the technology to double-sided tape; each side can be customized to the active molecule or surface. Dosage and delivery of the drugs are also customizable. Because of this capability, IFBMs can be used for site-specific biological delivery. “This avoids systemic delivery of drugs and reduces the amount of drugs that might be placed at a site by the device,” Anderson says.

In addition to binding small-molecule drugs like antimicrobial agents, analgesics, and steroids to medical devices, the company also is exploring surgical applications for the IFBMs, such as protein delivery from scaffolds. “We can control the dose and release of growth factors and other proteins when used in surgical procedures,” Anderson says. “This is important because the recombinant proteins are potent, expensive, and need to be targeted.”

The peptide coatings also have demonstrated the ability to accelerate the natural healing process and to preferentially bind cell populations to a surface. “We think of this as kick-starting the natural biological processes,” Anderson says. Unlike traditional polymer coatings that may create inflammatory responses, the peptide coatings can naturally resorb into safe by-products, he adds.

Unlike polymer coatings, which must be applied to devices prior to going to market, IFBMs have the potential to be applied to devices immediately prior to implantation, according to Anderson. The company is compiling a menu of possible coatings for different medical devices as well as drug and biologic delivery for point-of-care applications.


Copyright ©2008 Medical Product Manufacturing News

Medtronic Patent Award Reduced

Court of Appeals for the Federal Circuit.