Archives: 2/2009

images9666 Inspire II Implantable Nerve Stimulator for Obstructive Sleep ApneaInspire Medical Systems, a spin-out of Medtronic, has developed an implantable electronic stimulator for the treatment of obstructive sleep apnea (OSA), and now implanted it in a first patient. Because muscles in the upper airway relax more than necessary in some OSA patients, the passage gets blocked and air can’t flow repeatedly during sleep. The company’s Inspire II System applies an electric current to the hypoglossal nerve at proper times by sensing the pulmonary pressure of the patient. Of note, Inspire Medical has received FDA approval for the device.
More about the device from the product page:

The Inspire II system consists of an implantable pulse generator, a pulmonary pressure sensor and a stimulation lead that delivers the electrical impulses to the patient’s hypoglossal nerve. The hypoglossal nerve is the twelfth cranial nerve that is located along the side of the neck and leads to the tongue. The unique closed-loop design of the Inspire II system senses a patient’s respiratory effort during sleep and provides hypoglossal nerve stimulation to maintain an open airway synchronous with respiration. Patients have a programming device that is used to turn the device on at bedtime and to turn the unit off during non-sleep periods. The stimulation delivered is sufficient enough to evoke a response from the nerve but at a low enough level to not disturb the patient’s sleep. A physician controller unit, used during visits to the patient’s treating physician, is used to monitor the therapy and make adjustments to the device as needed for the patient’s unique physiology

Press release: Inspire Medical Systems Completes First Implant of the Inspire II System to Treat Obstructive Sleep Apnea …
Product page: Inspire II System …

serica logo Silk Based Synthetic Surgical Scaffold Gets FDA ApprovalSerica Technologies, Inc. out of Medford, Massachusetts has received FDA approval for the SeriScaffold™, the company’s long term bioresorbable surgical mesh made out of a proprietary silk-based material.
The press release says that for now the company is aiming its product primarily at plastic and reconstructive surgery market, but other procedures, including rotator cuff and hernia repair surgeries, could benefit from this material:

The SeriScaffold platform technology has the potential to provide a new solution as an off-the-shelf, long-term bioresorbable scaffold for support and repair of weakened or damaged connective tissue. Most notably, SeriScaffold could be used as a sophisticated tissue repair scaffold for the approximately 60,000 women who, according to the American Society of Plastic Surgeons, annually undergo reconstructive procedures resulting from illnesses such as breast cancer.
“Major challenges still exist for both surgeons and patients faced with breast reconstruction and other forms of plastic and reconstructive surgery,” said John E. Gross, MD, FACS, Associate Professor of Surgery at the University of Southern California (USC/Keck) School of Medicine and a prominent practicing plastic surgeon in Greater Los Angeles. “For example, in many types of breast surgeries, either following mastectomy, mastopexy (breast lift) or body contouring procedures, there is a significant need for scaffolding technology that can immediately support a geometrically complex implantation site at the time of surgery, and provide the body both the time and structure necessary for optimal healing. A silk-based scaffold that supports immediate tissue
infiltration and maintains its integrity over a longer term, as it is being bioresorbed by the body, may be significant in addressing these clinical needs.”
In pre-clinical studies, Serica’s silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, as well as other water soluble synthetic polymers, to enable optimal healing. Serica’s silk-based biomaterials require no re-hydration or advance preparation for surgical implantation.

Press release: Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold™ Technology for Soft Tissue Repair
Product page: SeriScaffold …
Relevant article abstract: The Use of Long-term Bioresorbable Scaffolds for Anterior Cruciate Ligament Repair

capnostream Capnostream 20, a Smart Capnography System,  Gets FDA OKOridion Systems Ltd., a company out of Jerusalem, Israel, has received FDA 510(k) approval to market the firm’s Capnostream 20 CO2 Monitor with Integrated Pulmonary Index™.
Features from the product page and the press release:

The Integrated Pulmonary Index™, the latest Oridion Smart Capnography™ initiative, utilizes sophisticated algorithms to integrate the real time measures and interactions of four complex parameters – end tidal CO2 (EtCO2), respiration rate, pulse rate and SpO2 (oxygen saturation) into a single index value. The result is displayed on a scale from 1 10, where 10 indicates optimal pulmonary status.
By using the Integrated Pulmonary Index™, clinicians can quickly and easily assess a patient’s ventilation status and monitor a patient’s changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes.

  • Dual parameter monitor
    Supports the current standard of care providing CO2 and a compatible range of SpO2 technologies and sensors
  • Simple user interface with color screen
    Routine functions are accessed with 2 clicks
  • 72 hour trends
    Review patient history
  • Event marking
    Compare events and medication administration to changes in patient status
  • Nurse call
    Keeps you in touch with the status of your patients
  • Internal printer
    Convenient bedside documentation
  • We think that such a device might come in handy for a variety of clinical settings, such as monitoring of patients during office-based anesthetics, recovery room monitoring, anesthesia in endoscopy suits, etc.
    Press release: Oridion Receives FDA 510(k) Clearance for Capnostream™ 20 Monitor with Integrated Pulmonary Index …
    Product page: The Capnostream™ 20 …

    cttpaintherapy Electrical Nerve Stimulator for Drug Resistant Pain Gets Green Light in U.S.The FDA has given 510(k) approval to Competitive Technologies, Inc. (Fairfield, CT) to market a pain management device for cases that are not sufficiently responding to drugs and other therapies. The company says its electromedical system sends electronic scrambling messages to the central nervous system, and effectively tricks the body to believe that all is well.
    From the product, described as a “transcutaneous electrical modulation pain reprocessor”:

    Description:
    The pain management therapy technology is a non-invasive method for rapid treatment of high-intensity oncologic, neuropathic, and drug-resistant pain through a biophysical rather than a biochemical manner. The method incorporates electromedical equipment for electronic nerve stimulation, and uses the nerve fiber as a passive means to convey a message of normality to the central nervous system (CNS) by a procedure defined as scrambling or tricking of information, which then enables the CNS to modify the reflex adaptive responses — referred to as TEMPR — Transcutaneous Electrical Modulation Pain Reprocessor. It has been successfully used to treat over 2,300 patients in hospitals in Italy.
    Advantages:
    The non-invasive MC-5A device, using Scrambler technology, is a multiprocessor apparatus able to simultaneously treat multiple pain areas in the individual. The patient experiences longer "no pain" periods after each successive treatment.
    Applications:
    The global pain management market is estimated to reach $40 billion by 2010. Potential market opportunities include hospitals, nursing homes and hospices, cancer treatment centers, and pain management centers.

    Product page: Pain Management Therapy…
    Press release: Competitive Technologies Receives FDA Authorization for Sales of Pain Therapy Medical Device …
    Link to interview with Competitive Technologies CEO about the approval…

    There will be no posts today. Thanks for stopping by and we’ll see you here tomorrow.

    546746yet Magnetic Beads for Reflux?
    Gastroesophageal reflux disease (GERD) is considered to be a structural disorder. Usually the problem lies in the lower esophageal sphincter, that in certain patients is a little too loose at times, sending acidic stomach contents back up into the esophagus. The disease can lead to painful erosive esophagitis, or even serious conditions such as esophageal cancer.
    A new clinical trial for the LINX Reflux Management System, a product of Torax Medical, Inc. (Shoreview, MN), is being conducted at selected U.S. and European centers. The device, described as a “bracelet” around the Lower Esophageal Sphincter composed of a series of miniature magnetic beads, can be implanted laparoscopically.
    One of the hospitals in the United States, the UC San Diego Medical Center, is now actively participating in this early trial, as its press release testifies:

    During a 20-30 minute minimally invasive surgical procedure, the device, made up of a series of magnetic beads, is secured around the bottom of the esophagus. Once in place, the magnetic attraction between the beads supports the valve to protect the esophagus from reflux, while still allowing it to open during swallowing or to release gas. Made of permanent rare earth magnets encased in titanium, the band is sized to fit each patient.
    mag gerd Magnetic Beads for Reflux?“With medical therapy alone, the production of acid in the stomach is suppressed, but the actual problem of reflux remains. The most appropriate long-term therapy for GERD is to restore the body’s physiological barrier to correct the cause of reflux itself,” said Horgan, the first surgeon in the western United States to implant the device in this clinical trial.
    “I decided to participate in this clinical trial surgery because it may be a permanent, structural way of addressing the problem,” said Gina Levine, age 43, who has suffered from GERD for more than 18 years. “I like the minimally invasive approach to this procedure and that it can be reversed if necessary.”

    And here’s the information about the procedure, from a Torax Medical website:

    The LINX™ procedure is performed by a surgeon using a minimally invasive surgical technique, called laparoscopy. The device is placed around the distal esophagus, just above the stomach, in the area of the Lower Esophageal Sphincter (LES).


    Once the device is placed it will begin working immediately; magnetic attraction between the beads helps to keep the lower esophageal sphincter closed to prevent reflux, but will open to allow swallowing or the release of higher gastric pressures.
    Following the procedure, under physician guidance, patients should be able to resume normal diet and will typically resume normal activities in less than a week.

    Our guess is that the device will have to significantly outperform currently available therapies, such as open and Nissen fundoplications, before it is approved. But given the limited surgical therapeutic options nowadays, we really hope that the LINX Reflux Management System makes it through the trials and onto the surgical field.
    For now, an empty trial page at ClinicalTrials.gov…
    Product page: LINX™ REFLUX MANAGEMENT SYSTEM…
    Read the UC press release here

    rezareza New Negative Pressure Wound Care Device from Smith & NephewAt the ongoing American Academy of Orthopaedic Surgeons Annual Meeting in Las Vegas, Smith & Nephew has just introduced a new negative pressure wound therapy system called RENASYS EZ.
    Features and functions according to the manufacturer:

    In addition to a simple control that varies pressure from 40 to 200 mmHg and the ability to use both foam and gauze dressings, Smith & Nephew designed RENASYS EZ with additional features that enhance the patient experience and facilitate its ease of use.

  • An intuitive design and quick-click connectors can help reduce the risk of error.
  • Multiple safety alarms and a patient lock-out feature alert clinicians to changes in pressure status or pump function.
  • The RENASYS EZ battery runs for up to 40 hours and charges in three hours.
  • A convenient IV pole and bed mounts reduce the system’s footprint at the patient’s bedside.
  • The system weighs only 7.4 lbs, reducing stress on the caregiver.
  • Press release: Smith & Nephew announce the new RENASYS EZ system for Negative Pressure Wound Therapy …

    arm22222222 DIY Culture Now Encompasses Home Made ProsthesisA Tasmanian man, who lost his arm in a car accident, was told that he is a poor candidate for a prosthetic, since the amputation is too high for conventional devices. Being a rebel Aussie, Mark Lesek ignored the advice, and traveled to Sweden to implant a metal rod into his shoulder that can support a new prosthesis. The arm that he is now happily wearing is one he built with help from a business partner, and the project has developed further to include the University of Tasmania bioengineering team. The next step is to involve researchers that can help with lightening the unit using carbon fiber, and to create brain-computer interface to make the arm semi-autonomous.
    More from The Mercury out of Hobart, Tasmania…
    (hat tip: Gizmodo)

    fslogologo Frost & Sullivan Annual Medical Devices MindXchangeMedgadget is partnering with Frost & Sullivan for this year’s 14th Annual Medical Devices MindXchange, a gathering of industry professionals to discuss the status and challenges of the business. To be held March 15 – 17 at the Hyatt at Fisherman’s Wharf in San Francisco, this is one of the premiere events in the industry, annually bringing together executives in one place to share and discuss common issues affecting everyone in our fast developing field.
    Here’s what Frost & Sullivan says about the conference:

    Your industry is changing…and so are your customer’s expectations. Challenges abound…and so do opportunities for growth. Medical Devices 2009 Executive MindXchange – now in its fourteenth year – brings you a comprehensive and up-to-the-minute perspective of the industry, and an awareness of trends and market forces that will significantly alter the landscape of the industry.
    The 14th Annual Medical Devices MindXchange will deliver strategies and best practices for growth, along with executive insight and success stories. It’s the only place to be to network with and learn from other seasoned medical devices executives driving their company’s innovation, growth, and business strategy. The groundbreaking format propels networking to a new level, maximizes pollination of ideas among industry cross-sections, and delivers concrete value to your business.

    Visit the conference website for more info and registration options…