With medical device OEMs requiring smaller, lighter, and longer lasting devices, Suntron Corp. officials announce that they have the capability to place and inspect the tiny packages needed for miniaturized medical device electronics.  

Suntron builds highly complex boards with 01005 components requiring the control of many variables during assembly process. The 01005 case size is half the size of the 0201, previously considered to be the smallest case size in Surface Mount Technology. Due to the component’s tiny size, well-planned modifications to the paste application and placement processes are necessary to achieve success.

In addition to placement, Suntron has the expertise and dedicated resources, including a state-of-the-art imaging machine, to inspect the printed circuit boards (PCB) and detect defects. While some manufacturers are reluctant to take on the upfront cost of purchasing new equipment, Suntron believes that it is necessary to ensure product quality. 

“You can place 01005s and 8 mil pitched micro BGAs without the most current equipment,” explains Bill Dampier, senior manufacturing & process engineer, Suntron. “But unless you have a machine that will give you a visual of the castellation joint on one of those 01005s, or an X-ray machine that will zoom in on that micro BGA joint so you can confirm what you’ve done, you can’t be sure of the product quality.”

To complement its extensive inspection process, Suntron is ISO 13485 certified and FDA registered and offers manufacturing facilities that meet the strict quality demands of the FDA’s Good Manufacturing Practice (cGMP) standards, defined by FDA 21 CFR Part 820 QSR. Suntron also offers clean rooms in all of its facilities for assuring clean assembly processing and packaging critical clean products.

Siesta Medical Inc., a provider of minimally invasive surgical implants and tools for obstructive sleep apnea (OSA), received additional FDA clearances for its Encore Tongue Suspension System.

Siesta’s Encore System simplifies and improves the control of tongue suspension, a minimally invasive treatment for OSA recently endorsed by the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) as an effective treatment used to manage patients suffering from OSA. The Encore’s latest FDA clearances make it the only multiple suspension loop and fully adjustable tongue suspension system on the market.

Traditional tongue suspension has been limited to the placement of a single suspension loop with a fixed amount of tension. This may result in residual airway obstruction behind the tongue base or a sub-optimal amount of suture tension. Siesta’s Encore System overcomes this limitation with unique suture passer and bone anchor technology, giving the physician the freedom to place multiple suspension loops that can have their tension easily adjusted during and after the procedure.

Dr. Jeffrey Kirsch at Conway Regional Hospital in Conway, AR comments, “The multi-level approach with Encore system allows me to readily control the airway space behind the tongue base. It’s a quick and minimally-invasive procedure. The patients I have treated are feeling better, snoring less, and their follow up sleep studies show impressive drops in OSA severity.”

Experienced Encore physicians also expressed their support for the recently adopted AAO-HNS tongue suspension policy. Dr. Jason van Tassel at Washington Hospital in Fremont, CA states, “I am pleased to see the academy coming out in support of tongue suspension. I have performed hundreds of tongue suspensions with a very high success rate even for my high BMI patients. Multi-level sleep surgery has freed my patients from CPAP devices and for the tongue base, Encore is my intervention of choice.”

“Siesta believes the Encore System is a clinically and cost effective surgical option for treating OSA patients unable to comply with CPAP use. We are gratified that our users have consistently endorsed the clear product and procedural advantages the system delivers,” says Peter Martin, president and CEO, Siesta Medical, Inc.

Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is a major health problem in the United States. An estimated 15 million people in United States have moderate to severe OSA (Canaccord Adams, Daily Letter, June 21, 2007), which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. If left untreated, OSA has been implicated in the increased risk for cardiovascular disease, including hypertension and heart failure. Despite its prevalence and role as a cardiovascular risk factor, OSA remains largely under diagnosed.

The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. While effective, CPAP is difficult for patients to use.

Although surgical therapy for OSA is currently less common than CPAP therapy it provides an important and effective alternative for those patients who are not compliant or have difficulty with CPAP therapy. There are over 1 million new diagnoses of OSA in the U.S. each year and nearly 100,000 surgical procedures for OSA performed annually.

The Encore Tongue Suspension System
Use of the Encore System is in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing its collapse into the airway during sleep. The procedure is performed under local or general anesthesia by Ear, Nose, and Throat Specialists, also known as Otolaryngologists, and takes typically less than 40 minutes to perform.

Moog Medical Devices Group officials announce that customers and users of enteral feeding products manufactured and distributed by Abbott Nutrition should be confident that there is enough product in the marketplace to meet new and on-going demand for enteral feeding pumps and sets. 

"With the exit of Abbott Nutrition from the enteral device feeding market, we are seeing some confusion from clinicians and customers regarding pump and set availability," states Mike Henderson, group vice president of operations, Moog. "From Moog's perspective, we are confident that our strategy and manufacturing plans assure that current and future customer needs can be met."

Upon the announcement by Abbott's management regarding its market exit, Moog negotiated the re-purchase of all Moog EnteraLite Infinity assets from Abbott's inventory. This allows current Abbott customers, buying under existing agreements, to continue to do business as usual with Moog. Additionally, set acquisitions will continue with Abbott until February 16, 2013. After this date, Moog will provide administration sets to customers, and will honor all existing terms and agreements previously held by Abbott.

Moog provides enteral feeding pumps that are suitable for both clinical and home use. Our pumps also provide an easy transition from a clinical setting to the home. Some key features include:

• A total weight that is less than 1 lb and designed for both pole and carry pack use
• More precise flow rates from 0.1mL/hour to 600mL/hr
• Maintains ±5% accuracy when used at any flow rate
• Rugged design to eliminate the need for regularly scheduled maintenance
• Easily cleaned by rinsing under running water
• Purple safety screw connectors are available to prevent accidental connection to IV tubes
• Comprehensive product training and support available

While the Infinity EnteraLite is best known for home healthcare use, Moog's enteral feeding pumps are gaining popularity in clinical settings due to their ease of programming, quiet operation and the total cost of ownership value they provide to facilities. 

"Our goal is to help clinicians and patients manage feeding schedule compliance," Henderson adds. "Moog's market leading product line of ambulatory enteral feeding pumps are at the forefront of providing patients a more typical lifestyle and clinicians the ability to focus on other areas of care."

Teleflex Inc. officials announce the expansion of the company’s portfolio of Hudson RCI respiratory solutions for the critical care infant as part of its Breathing, Made Easier campaign. The addition of the Babi.Plus Bubble PAP Valve for nasal continuous positive airway pressure (NCPAP) strengthens the Teleflex respiratory product portfolio, which already includes the Hudson RCI Infant Nasal CPAP Cannula System and the ConchaTherm Neptune Heated Humidifier.

The Babi.Plus Bubble PAP Valve provides a convenient, economical means to apply positive airway pressure to critical care infants. The unique design delivers accuracy and stability throughout the course of therapy, allowing the clinician to focus more on patient care and less on the device. The Babi.Plus Bubble PAP Valve is low-maintenance, and the ergonomic design allows airway pressure to be easily set without the cumbersome time-consuming tasks typically associated with bubble devices.

The Hudson RCI respiratory solutions also include the Hudson RCI Infant Nasal CPAP Cannula System, which features soft, anatomically curved prongs that enhance patient fit and a luer fitting on expiratory connector that allows proximal airway pressure monitoring.

In addition, the unique components of the ConchaTherm Neptune System work together to deliver optimal humidification for the critical care infant while simultaneously maximizing clinician efficiency. The ConchaTherm Neptune Heated Humidifier features an adjustable airway temperature and gradient control that allows clinicians to customize therapy – maximizing humidity delivered while minimizing circuit condensation. The selection of breathing circuits, Concha Column and accessories are designed to support a wide range of ventilation strategies for the critical care infant.

“We are excited about the addition of the Babi.Plus Bubble PAP Valve to our comprehensive portfolio of respiratory solutions for the critical care infant,” says Cary Vance, president, Anesthesia, and Respiratory Division. “At Teleflex, we are committed to helping clinicians improve patient outcomes and reduce healthcare costs through our Breathing, Made Easier initiative.”