Wednesday, November 19, 2008
Smarter Pill Bottle Caps
Glowcaps are a simple solution to an old problem of daily medication compliance by patients of any age or size. Designed to remind people to take their daily meds, the standard pharmacy bottle sized caps keep track of when they're opened and remind patients with a blinking light to take the pills inside. If the patient doesn't comply, the cap plays a regularly repeating ring tone until it gets its deserved attention. The caps are finally available for purchase through Amazon at $30 a pop.
Product page: Glowcap Solo ...
And for $30 on Amazon...
Flashbacks: Glowing Caps Raise Compliance, Send Coupons
(0)
Wednesday, November 12, 2008
How Math May Solve Septicemia
The next time your teenager complains, "But when am I ever going to use this?", referring to math they are learning in school, now you can reply, "Septicemia!"
As we know, septicemia occurs when bacteria enter the bloodstream from an infected organ or site, and despite many methods designed to reduce the spread of infections, fighting infections with antibiotics once they occur, and other supportive therapies, septicemia, or a resultant sepsis, remains a leading cause of death in hospitals. Could mathematics help us solve this problem?
Well, the University of Michigan School of Medicine is researching mathematical approaches that may become a powerful ally in hunting down and destroying the bacteria that cause septicemia. Using complex mathematical techniques that model bacteria behavior in the bloodstream, scientists may be able to offer a mechanical approach to help rid the body of bacteria, which would be a welcome addition to our declining list of effective antibiotics.
From the story released by the University of Michigan:
John Younger M.D., M.S., and his team have more research to do before their models yield results that might affect human treatment. But already, they are seeing the potential for how to improve the models and use them to simulate different aspects of human bacteremia and sepsis."We're trying to understand the rules for how bacteria traffic in the bloodstream - and if you understand the timing of those events you might be able to better understand how best to detect the bloodstream infection when it's present," he says. "We're also working on ways to fundamentally change the rules of engagement between the bacteria and the host. There are mechanical features at play in terms of getting these bacteria in flowing blood out. If we can change the mechanics of that interaction, then we can potentially have a therapy that the bacteria don't really have an opportunity to defend against or develop resistance against. And that could be a useful therapy."
(4)
Tuesday, November 11, 2008
Continuous Noninvasive Blood Pressure Monitoring with CNAP Monitor 500
CNSystems Medizintechnik AG, a medical technology firm out of Graz, Austria, has received FDA approval to market the company's CNAP™ Monitor 500, that performs continuous noninvasive blood pressure monitoring. The unit can be used in conjunction with other monitoring systems or alone as a self contained, battery powered unit.
More about the technology and the device from the press release:
CNAP™ traces blood pressure changes through the patented CNAP™ cuff at the fingers and calibrates the derived values once in a while to an upper arm measurement. This way the physician is provided with blood pressure values is the one he/she is familiar with and the patient's individual physiology is optimally taken care of. If the position of measurement is changed relatively to heart height, just trigger a new upper arm measurement for the recalibration to the new measurement situation...The CNAP™ Monitor 500 measures non-invasive and continuous blood pressure in real-time and can predict responsiveness to fluid administration. In the perioperative setting, detecting blood pressure drops and their cause in time is crucial for peri- and postoperative outcome. However, until recently only invasive methods provided quality information to the clinician. CNAP™ provides reliable blood pressure monitoring comparable to invasive techniques and adds valuable information about fluid responsiveness of the patient non-invasively. This allows spreading the highest level of blood pressure monitoring to all perioperative settings where close blood pressure monitoring is indicated, but the risk and discomfort of invasive measurement is not justified.
Product page: CNAP™ Monitor 500 ...
Press release: CNSystems Medizintechnik AG Receives FDA Approval for CNAP(TM) Monitor 500...
(0)
InterVene Needle Prevents Accidental Pricks
Medica 2008 conference in Düsseldorf is next week, but all sorts of companies are already showcasing their devices and technologies. InterVene Ltd. out of Staveley, UK has announced that the company will be presenting to the world its manually retractable hypodermic safety needle that goes on all sorts of commonly-used luer lock or luer slip syringes via an extrinsic attachment. Interestingly, despite this arrangement the device has only 0.03ml of dead space, "significantly less than the potential residual contents of the needle itself and well within the requirements of the International Standards Organisation (ISO) for deadspace," the company says. The company also proclaims that InterVene Safety Needle is "the world"s first manually retractable, hypodermic safety needle." But we are not 100% sure about that, to be frank.
Nonetheless, here are the features from the product page:
Cost-effective solution to reduce needlestick injuries Quick and easy to use, varying little from standard practice Fits commonly-used luer lock or luer slip syringes Fingers need never go forward of the contaminated needle Low angle of entry and auto-alignment of bevel during venepuncture [sic] Single-handed operation possible throughout Impossible to reuse once the safety feature has been activated Complies with ISO standards for deadspace Suitable for intravenous, intramuscular and subcutaneous injection Completely eliminates the chances of re-capping the needle cannula Available in a variety of gauge sizes
InterVene Safety Needle works particularly well with certain blood collection systems as a multi-sample needle.1. Automatic bevel alignment speeds up the needle insertion process.
2. The needle's offset design offers a very shallow angle of entry to the vein reducing the risk of popping the vein.
3. The transparent cap of InterVene Safety Needle ensures that flashback visualisation of blood is immediate.
These features are designed to assist the phlebotomist whilst offering a safety needle and reducing disposal costs.
Device page: InterVene Manually Retractable Hypodermic Safety Needle ...
Press release: World's first manually retractable safety needle unveiled at MEDICA ...
(0)
Monday, November 10, 2008
Intel Health Guide Undergoing Trials
According to Planetary Gear, a blog at CNET, Intel has announced a number of pilot programs to test the company's recently approved Health Guide PHS6000 device (see our previous post: At-Home Monitoring Solution from Intel ). The unit, coupled with enterprise software, allows patients to communicate via video and voice with their health care providers, manage data from at-home diagnostic devices, and receive relevant information about their conditions. The company is partnering with Aetna, Scan Health Plan, Erickson Retirement Communities, and the Providence Medical Group in Oregon to enroll patients and physicians to assess the benefits and challenges of the telehealth system.
Some basics about the device from Intel:
The Intel Health Guide is a comprehensive solution, combining an in-home patient device, as well as an online interface allowing clinicians to monitor patients and remotely manage care. The solution offers interactive tools for personalized care management and integrates vital sign collection, patient reminders, multimedia educational content and feedback and communications tools such as video conferencing and e-mail. The Health Guide can connect to specific models of wired and wireless medical devices, including blood pressure monitors, glucose meters, pulse oximeters, peak flow meters and weight scales. The Health Guide stores and displays the collected information on a touch screen and sends to a secure host server, where health care professionals can review the information. Patients using the Health Guide can monitor their health status, communicate with care teams and learn about their medical conditions.
More about the trials from CNET's Planetary Gear...
Report from Wall Street Journal: Intel Takes Step Into Home Health Care...
Intel Health Guide PHS6000 product brochure (.pdf)...
Intel Personal Telehealth Overview ...
(2)
Friday, November 7, 2008
Scientists Solve Structure of Oncolytic Lung Virus; Plan Viral Attack on Lung Cancer
Here's an interesting, and promising, new way to tackle lung cancer. At Argonne National Laboratory scientists have deciphered the structure of a virus that seems to selectively infect small-cell lung cancer cells. The virus, known as Seneca Valley Virus-001 (or NTX-010) was originally identified by a company called Neotropix out of Malvern, Pennsylvania. According to Neotropix, who is the owner of NTX-010, this unique pathogen...
"...is the only oncolytic virus that is not inhibited by any component of human blood that would prevent the virus from circulating, reaching tumor masses, and infecting them at reasonable doses. Systemic delivery is the only route of administration to reach all metastases in the body. NTX-010 can be delivered systemically and does not require intratumoral delivery like most other oncolytic viruses in development. NTX-010 is also unique in that it can be produced to an extremely high level in cell lines that have already been approved by the FDA as suitable cell lines for manufacturing. Since it is a native, unaltered virus, there is no chance to generate recombinants as observed for other viruses. Finally, NTX-010 targets cells having altered pathways known to be critically involved in metastases and invasion. "
More from Argonne NL about the effort to identify the structure of the virus:
The 3-D structure of the virus, known as Seneca Valley Virus-001, reveals that it is unlike any other known member of the Picornaviridae viral family and confirms its recent designation as a separate genus "Senecavirus." The new study reveals that the virus's outer protein shell looks like a craggy golf ball—one with uneven divets and raised spikes—and the RNA strand beneath it is arranged in a round mesh rather like a whiffleball."It is not at all like other known picornaviruses that we are familiar with, including poliovirus and rhinoviruses, which cause the common cold," says the study's senior author, Associate Professor Vijay S. Reddy, Ph.D., of The Scripps Research Institute. "This crystal structure will now help us understand how Senecavirus works and how we can take advantage of it."
The Senecavirus is a "new" virus, discovered several years ago by Neotropix Inc., a biotech company in Malvern , Pa. It was first thought to be a laboratory contaminant, but researchers found it was a pathogen, now believed to originate from cows or pigs. Further investigation found the virus was harmless to normal human cells, but could infect certain solid tumors, such as small-cell lung cancer, the most common form of lung cancer.
Scientists at Neotrophix say that, in laboratory and animal studies, the virus demonstrates cancer-killing specificity 10,000 times higher than seen in traditional chemotherapeutics, with no overt toxicity. The company has developed the "oncolytic" virus as an anti-cancer agent and is already conducting early phase clinical trials in patients with lung cancer.But the researchers still did not know how the virus worked, so they turned to Reddy. He and his Scripps Research team, especially Sangita Venkataraman, Ph.D., a postdoctoral researcher, determined the Senecavirus crystal structure.
Reddy describes the differences they found between other picornaviruses and the Senecavirus as like variations among car models of the same manufacturer. "The chassis is the same, but the body style is different," he says. "How the body of a virus is shaped determines how it infects cells."
The structure of the Senecavirus is also depicted at http://viperdb.scripps.edu/ , the "Virus Particle Explorer" developed at Scripps Research by Reddy and his colleagues. The online database is a worldwide resource for information on the structure of viral particles; it contains details of 253 viruses to date.
Argonne press release: Researchers seek to understand and improve virus that infects lung cancer cells ...
Neotropix Technology Platform ...
Structure of Seneca Valley Virus-001 @ VIPERdb...
(0)
New Revaclear Dialyzers Promise Cleaner Results
Gambro, a manufacturer of dialysis products based in Denver, Colorado, is releasing the next generation of high-flux dialyzers, devices that the company hopes will take high-porosity, biocompatible, high-flux hemodialysis to a new, and even an environmentally friendly, level.
The following features and benefits are taken from Gambro press statement:
The Polyflux Revaclear and Polyflux Revaclear MAX high-flux dialyzers feature a new membrane that is more efficient and more selective while retaining the same proven 3-layer membrane structure as the existing Polyflux dialyzer. The membrane is composed of a unique blend of the polymers PAES (Polyarylethersulfone) and PVP (Polyvinylpyrrolidone).Studies have demonstrated that the Revaclear dialyzers’ advanced design offers enhanced performance with a smaller, smoother membrane surface, with the potential to improve patient outcomes and efficiencies for providers:
• A smoother membrane surface area results in reduced thrombogenic potential
• Improved hollow fiber geometry, with thinner fibers, allows Revaclear MAX to achieve the same degree of solute clearance as the original Polyflux, despite a significant reduction in membrane surface area.
• A β2-microglobulin clearance that results in significant potential for lowering β2-microglobulin levels which may help to reduce morbidity and mortality in patients.
• Improved device design provides a uniform flow distribution in both the blood and dialysate compartments, contributing to enhanced solute clearance and low thrombogenicity.
The design and performance ensure that all adult patients can be treated using only two sizes of dialyzers — (Polyflux Revaclear (1.4m2) and Polyflux Revaclear MAX (1.8m2).
Press release: Gambro launches the next generation of high-flux dialyzers with Polyflux Revaclear and Polyflux Revaclear MAX
Revaclear Spec Sheet (.pdf)...
(0)
Thursday, November 6, 2008
An Insulin Pump You Can Show Off
Jiri Bukvald, a Czech product developer, has proposed this beautiful design for an insulin pump that looks like it's straight out of Star Trek. The OLED display uses little power and looks almost like printed paper, providing easy readability while using little precious battery power to extend the time between recharges.
More from Jiri Bukvald...
(hat tip: Yanko Design)
(1)
Wednesday, October 29, 2008
New Approaches To Combat Flu...Coming Soon?
The Pennsylvania Department of Health announced the first laboratory confirmed case of influenza on October 24th, so it's time to line up for your shot. This year's vaccine will be delivered the same way as usual, but new research may change future practices.
First, we want to talk about the study, released October 26th by Sanofi-Aventis, that looked at high-dose influenza vaccine response among adults over 65 years of age, when compared with the standard influenza vaccine.
Study authors explain, however, that as people age, the immune system tends to weaken. Older adults become not only more susceptible to infections, but also less responsive to vaccination. When infected with the influenza virus, they are less able to mount an immune response to neutralize the attack. "Development of an influenza vaccine that will provide an improved immune response in older adults is important because this population has the highest rates of complications from influenza including hospitalization and death," said Ann R. Falsey, MD Associate Professor of Medicine, University of Rochester School of Medicine, Rochester, NY; Infectious Diseases Unit, Rochester General Hospital. Approximately 90 percent of the 36,000 average annual influenza-associated respiratory and circulatory related deaths occur among adults 65 years of age and older.The standard influenza vaccine contained 15 micrograms of hemagglutinin (HA) of each of three influenza strains, and the high-dose vaccine contained four times as much, 60 micrograms HA per strain. Both vaccines contained two influenza type A strains (H1N1 and H3N2) and one influenza type B strain.
Twenty-eight days after vaccination, a higher percentage of the subgroup given the high-dose vaccine developed seroprotective HAI titers of 1:40 or greater to each of the three vaccine strains compared with those given the standard vaccine. In addition, mean HAI titers for all strains were higher in the seronegative individuals who received the high-dose vaccine compared with those who received the standard vaccine.
On another front, NanoBio Corporation, a University of Michigan spinoff whose nanotechnology to deliver vaccines and pharmaceuticals transmucosally was profiled by us back in February, has just announced positive results from influenza vaccination trial:
"Our nanoemulsion-based intranasal vaccine adjuvant system represents a paradigm shift in vaccinology. It can be used to safely deliver multiple antigen types directly into the lining of the nasal mucosa, which is rich in dendritic cells that present the antigen(s) to the immune system," said James R. Baker, Jr., M.D., founder and chairman of NanoBio Corp. "The nanoemulsion adjuvant uniquely interacts with these cells to trigger unparalleled mucosal and systemic immunity.""A large, unmet medical need still exists for protecting people from influenza infection," Baker said. "The robust immunity and antigen-sparing capability demonstrated in this study are especially important for addressing this unmet need, as are the demands for a vaccine that would protect people in the face of a flu pandemic."
NanoBio plans to begin a phase 1 clinical study for seasonal influenza in the first half of 2009 and is currently initiating preclinical studies in pandemic flu.
Sanofi-Aventis press release: High-Dose Influenza Vaccine Shows Increased Immune... (.pdf)
NanoBio press release: Nanoemulsion-based Intranasal Influenza...
Technology page: NanoStat™ Platform...
NanoBio Influenza Mucosal Vaccine Program...
Image credit: Wikipedia: Influenza...
UPDATE: NanoBio has more good news about its technology. Nanostat drug delivery emulsions also appear to be effective against other scourges that have infected mankind...yes, toenail fungus and cold sores! If interested, check these: Topical Treatment for Cold Sores Achieves Efficacy of Oral Drugs; Represents Paradigm Shift in the Treatment of Skin Infections ...; NanoBio Demonstrates New Topical Approach to Treating Nail Fungus that Circumvents Problems of Current Therapy ...
(0)
Tuesday, October 28, 2008
Spiration IBV Bronchial Valve Gets FDA OK
IBV™ Valve, the Intra-Bronchial Valve from Spiration, Inc. of Redmond, Washington, has been given Humanitarian Device Exemption (HDE) approval from the FDA "to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged,following lobectomy, segmentectomy, or lung volume reduction surgery." We've been following this device since 2005, and had a report earlier this month on the European approval of this device for precisely the same indications.
“This FDA approval, the first for a lung device in recent memory and the first ever for a bronchial valve, is an exciting milestone and marks an advancement toward broader FDA approval of devices to treat various types of lung conditions,” said Rick Shea, president and CEO, Spiration®. “As one of only three HDE approvals so far in 2008, this approval is a significant accomplishment for Spiration.”
“Although rarely life threatening, prolonged post-operative air leaks can be a significant and costly complication of lung surgery,” said Daniel Sterman, M.D., director of Interventional Pulmonology at the University of Pennsylvania Medical Center in Philadelphia. “The HDE approval of the IBV Valve System will have a positive impact on the lives of patients who are having difficulty recovering from lung surgery. We are pleased that this approval provides a new treatment alternative for these patients.”
Product page: IBV Valve
Flashbacks: Spiration IBV Valve Shows Promise in Treatment of Persistent Air Leaks; IBV™ Valve: Intra-Bronchial Device for Emphysema; IBV™ Valve Might Prevent Surgery for Some
(0)
Friday, October 24, 2008
Continuous MicroCHIPS Glucose Monitoring Shows Promise
Popular Science is reporting on the work of MicroCHIPS, a Bedford, Massachusetts firm that's designing under-skin implantable devices to measure chemicals and deliver drugs. The exciting news is that the firm will be performing clinical trials next year on its glucose detecting microchip, a device that has apparently shown positive results when studied on animals.
From the company technology page:
MicroCHIPS' technology is based on proprietary reservoir arrays that are used to store and protect chemical sensors or potent drugs within the body for long periods of time. These arrays are designed for compatibility with preprogrammed microprocessors, wireless telemetry, or sensor feedback loops to provide active control. Individual device reservoirs can be opened on demand or on a predetermined schedule to precisely control drug release or sensor activation.Our reservoir-based platform can also be used in passive control systems without microprocessors or power sources. MicroCHIPS' passive systems are designed to release or expose their contents based on the controlled degradation of polymeric matrices over time. These systems form the basis for miniature insertable devices that provide maximum flexibility for device placement.
More from Popular Science...
(hat tip: Gizmodo)
(0)
PainShield Gets FDA OK
NanoVibronix out of Nesher, Israel just received FDA approval for the company's PainShield device, a system that uses disposable electronically activated patches to deliver ultrasound to areas of localized pain.
From the product page:
The PainShield device is a portable, battery powered electronic unit that is connected to a disposable patch through which it delivers localized energy creating therapeutic effect to treat localized pain and induce soft tissue healing. This is made possible due to the company's proprietary technology which allows for the creation of a therapeutic transducer that can be made disposable and incorporated into a patch.The PainShield product uniquely generates and delivers localized, low frequency, low intensity therapeutic ultrasound by a self adhering patch, place next to the treated area for a period of time.
Product usage has shown wide range of applications including reduction of acute and chronic pain as well as an anti-inflammatory effect. PainShield may be used immediately post-injury and post-op. The product is patch based and does not require for medical personnel to apply it and hold it in place while receiving therapy.
Patient benefits include its ease of application and use, faster recovery time, high compliance, safety, and effectiveness.
Press release: NanoVibronix Receives FDA Clearance for its PainShield™ MD Device
Product page: PainShield
(0)
Friday, October 17, 2008
2 Points About DVT Ultrasonography
A study released in the October 8th edition of JAMA reports that when patients with suspected DVT of the lower extremities were investigated with 2-point ultrasonography (femoral vein at the groin and the popliteal vein at the popliteal fossa) plus D-Dimer it was as good a strategy as whole-leg ultrasonography for the management of symptomatic patients with suspected DVT.
Compression ultrasonography is a highly accurate method for the detection of deep vein thrombosis (DVT) in symptomatic outpatients and has replaced ascending venography and other diagnostic methods in common practice.Usually, only the proximal veins are investigated; namely, compression is applied to the common femoral vein at the groin and the popliteal vein at the popliteal fossa (2-point ultrasonography). Relevant features of this strategy are simplicity (may be proficiently learned in <2 hours), reproducibility, and broad availability (may be performed with virtually all ultrasound scanners, irrespective of age, model, and even of the probe frequency). Its major limitation is the need to repeat the test once within 1 week in patients with normal findings at presentation to detect calf DVT extending to the proximal veins (serial 2-point ultrasonography). Repeat testing may be safely avoided in patients with a normal D-dimer test result at presentation.
(0)
Thursday, October 16, 2008
Vibration Response Imaging (VRI) Shows Promise In Assessing Postoperative Lung Function
Lo and behold! If you are a thoracic surgeon, and you can't figure out whether your postoperative patient doesn't get enough of air because of an airleak or because of diminished functional capacity, you might have a noninvasive diagnostic option soon. Deep Breeze Ltd., an Israeli firm, is reporting that its pulmonary imaging technology, vibration response imaging (VRI™), has shown superior effectiveness "for the evaluation of lung function compared to functional respiratory tests, before and after thoracic surgery." We have covered this FDA-approved device on many occasions before, so check our flashbacks below. The VRIxp System is a noninvasive device that utilizes the body's intrinsic acoustic vibration signals from the lungs to develop dynamic images of functional intrapulmonary anatomy.
The following is from a press statement, issued by Deep Breeze, about the findings presented at the 18th European Respiratory Society Congress by Prof. Roberto Bossi from University of Milan:
Data showed that VRI allows better evaluation of lung volume regional variations after chest lobectomy compared to functional respiratory tests. “The advantages having a non invasive, patient's effort independent, easy to handle and readily available imaging modality for pulmonology are numerous,” said Prof. Bossi. He goes on to say: “A big benefit is that I can monitor and measure the gain or loss of lung function after chest surgery better than functional respiratory test.”
In addition Deep Breeze has launched a strategic program to include the VRIxp™ as an integral part of the guidelines for physiologic evaluation of patients with lung cancer being considered for resectional surgery. The feasibility of this program is currently being investigated by MD Anderson, and the leading investigator of this program Prof. Rodolfo Morice had this to add: "Lung cancer is the leading cause of cancer death in the USA and the world and surgery remains the best treatment option for patients with this condition. Predictions of postoperative lung function are crucial to maximize the number of patients that can benefit from surgery and identify patients with such poor respiratory reserve that lung resection would result in an unacceptable quality of life. These preoperative evaluations currently require radionuclide tests of ventilation and perfusion that require administration of radioactive isotopes and not always readily available.”
Company video introducing the device...
Press release: Deep Breeze Announces Latest Study Results on Vibration Response Imaging (VRI(TM)) at the 18th European Respiratory Society Congress
Flashbacks: New Pulmonary Imaging Modality Approved by the FDA ; Video of VRIxp System from Deep Breeze; The VRIxp System: New Noninvasive Way to Image Lungs
(0)
Wednesday, October 8, 2008
LIFEPACK 20e, Now With a Bigger Battery
Physio-Control, a subsidiary of Medtronic out of Redmond, Washington, won FDA approval for the LIFEPACK 20e defibrillator/monitor system.
The 20e is an enhancement of the LIFEPAK 20 defibrillator/monitor, which has become the standard of care in many hospitals worldwide since its introduction in 2002. It offers all the capabilities of the LIFEPAK 20 device, along with a more powerful Lithium-ion battery that doubles ECG monitoring time and the run time of other parameters such as noninvasive pacing and pulse oximetry, a noninvasive way to monitor the oxygenation of a patient’s hemoglobin. Additionally, a new on-screen “fuel gauge” displays the real-time status of available battery capacity so clinicians can monitor remaining use time.The 20e also was developed to be easily transported, helping hospitals meet the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) standard for having resuscitation services readily available in all facility areas.
Press release: Physio-Control Receives FDA 510(K) Clearance for LIFEPAK® 20e Defibrillator/Monitor
(0)
Spiration IBV Valve Shows Promise in Treatment of Persistent Air Leaks
Spiration, Inc out of Redmond, Washington received European approval to market the company's IBV™ Valve, an intra-bronchial device designed for the treatment "of diseased and damaged lung, an indication that includes the treatment of emphysema and the resolution of air leaks," according to the company. In addition, the firm is also reporting positive results from a small US compassionate use study of the device. We've been reporting about the Intra-Bronchial Valve (IBV™ Valve) since 2005. (Previously: IBV™ Valve: Intra-Bronchial Device for Emphysema; IBV™ Valve Might Prevent Surgery for Some.) The main idea behind the device is an improvement of a balance between ventilation and blood perfusion in the lungs, by blocking entrance of the air into diseased regions, and also by preventing air escape from air leaks.
From a press release obtained by Medgadget:
Daniel Sterman, M.D., director of Interventional Pulmonology at the University of Pennsylvania Medical Center in Philadelphia, presented an evaluation of the compassionate use of the IBV Valve System for the treatment of air leaks in six patients during this week’s ERS Annual Congress.Air leaks are a common complication of surgery caused by lung tissue that has not completely closed and sealed, resulting in an accumulation of air in the chest that can cause breathing difficulties. They can also result from serious diseases of the lung and contribute to significant morbidity and mortality.
“In these very complex compassionate use cases, the IBV Valve System was safe and effective for the treatment of air leaks,” said Dr. Sterman. “I believe this is a very promising clinical application for this device.”
The U.S. Food and Drug Administration’s (FDA) compassionate use provision allows access for patients who do not meet the requirements for inclusion in clinical investigation but for whom the physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition.
The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung. In Europe, the system has received market clearance through CE Mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks, a complication that can occur following lung surgery or as a consequence of certain serious lung diseases.
During the minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the bronchial tubes through the mouth or nose) to deploy the small umbrella-shaped valves into the airways of the lungs. The valves are designed to be easily removed via a similar bronchoscopic procedure.
Animation outlining implant functionality...
Product page: IBV Valve...
(0)
Catheter with SecurAcath Subcutaneous Mounting System Gets OK
Interrad Medical, a Minneapolis, MN firm, won FDA clearance for the catheter that features company's SecurAcath device, a system that grabs to subcutaneous tissue to anchor and secure the central line catheter.
The SecurAcath System utilizes a small anchor that deploys in the subcutaneous tissue just beneath the skin to hold an indwelling catheter securely in place. There are over 12 million venous access catheters placed each year worldwide. Currently, catheters are secured on the surface of a patient's skin using sutures or adhesive devices.The SecurAcath System offers significant advantages over current securement methods. The SecurAcath system is designed to improve catheter securement by decreasing catheter maintenance time and related costs, reducing catheter-related infections by improving cleaning of catheter exit site and minimizing catheter motion, decreasing skin surface issues, and eliminating needle stick injuries that may occur when suturing catheters.
The Company is currently developing a stand-alone SecurAcath device that can be used with virtually any indwelling catheter. The stand-alone SecurAcath is being designed to work with all PICC, CVC, dialysis and drainage catheters.
Product page: SecurAcath
Press release: Interrad Medical Receives FDA Clearance of World's First Catheter with Subcutaneous Securement System (.pdf)...