Posts by: Ronney Shantouf

Interview with David Steinhaus, VP of Cardiac Rhythm Disease Management at Medtronic

Last week Medtronic announced that the FDA has given the company  expanded indication for its portfolio of cardiac resynchronization therapy with defibrillator (CRT-D) devices to now treat mildly symptomatic, NYHA Class II heart failure patients. We had a chance to speak with Dr. David Steinhaus, M.D., Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business at Medtronic.

Ronney Shantouf, M.D., Medgadget: Can you explain the major difference between cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices vs. implantable cardioverter defibrillator (ICD) devices in terms what is implanted into the patient?

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The Future of InterVapor: Q&A with Uptake’s Chief Medical Officer Steven Kesten

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series C funding round, which will support commercialization of InterVapor for treatment of severe emphysema. This news comes on the heels of Uptake Medical receiving CE mark approval for InterVapor in September, completing the first commercial use of InterVapor in Germany in November, and recently announcing TGA approval for InterVapor to be marketed in Australia.

Steven Kesten, Chief Medical Officer at Uptake Medical, answered our questions about the company and its technology:

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New MRI Contrast Agent for Cancer Detection. A Game Changer?

Engineers at the University of Pennsylvania have developed a way to coat an iron-based contrast agent so it interacts preferentially with acidic environments in the body such as areas of tumor formation or inflammation.  The technology may lead to a potentially cheaper, safer, and more effective method of tumor detection than current less specific contrast agents.

The research was conducted by Professor Andrew Tsourkas and graduate student Samuel H. Crayton from the bioengineering department at Penn’s School of Engineering and Applied Science and published in the journal ACS Nano.  To improve the differentiation between tissues in the body, physicians use contrast agents to achieve better visualization of tissues when imaging.

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A New Device to Prevent Those Deep Vein Clots?

Deep vein thrombosis (DVT) is the formation of a blot clot in the deep veins, particularly the lower limbs. Bed-bound patients such as post-surgical hospitalized individuals are at a particularly increased risk of developing these clots.  DVTs can dislodge, reaching the pulmonary vasculature resulting in potentially life threatening pulmonary embolisms. Common prophylaxes include early ambulation, compression devices, and/or anti-coagulation therapy.  A new device, Geko by UK based Sky Medical, is a wristwatch sized product that stimulates the peroneal nerve via electrical signals leading to muscle activation of the lower limb, that has shown evidence of increased blood-flow in the femoral vein.  Preventing venous stasis can potentially lead to less clot formation. The small self-adhesive device is applied to the posterior knee with no need for wires or leads.  If proven effective, this can potentially alter current DVT prophylactic therapy.  Geko is CE Marked under the Medical Devices Directive. The device is currently not approved by the FDA and not available for sale in the USA.

Product page: Geko…

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HealthVault Windows Phone App Launched by Microsoft

Microsoft has released an official mobile app for its HealthVault PHR platform.  It is available free for smartphones using the Windows Phone 7 OS.  The app enables users to quickly input personal medical information such as allergies, immunizations, blood pressure and glucose readings, and much more. The app links with a cloud-based service and the can serve as a tool for patients to provide information to health care professionals such as nurses and doctors.

The HealthVault service first went mobile in June when it created a mobile optimized layout of its website and the app is a follow up to that.

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Kitware Receives Award to Develop an Augmented Reality System to Assist in Prostate Surgery

Kitware, an open-source software development company, has been awarded Phase I Small Business Innovation Research (SBIR) funding from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), through a unique joint agency initiative of The National Institutes of Health (NIH), Defense Advanced Research Projects Agency (DARPA), the National Science Foundation (NSF), the United States Department of Agriculture (USDA), and the Department of Homeland Security.

The funding will be used to create an augmented reality visualization prototype to improve the safety and efficacy of robot-assisted prostate surgery for those suffering from prostate cancer.  The project is to create a human/machine collaborative system to provide surgeons with an augmented reality (AR) view by fusing pre-operative MRI imaging of the prostate and surrounding tissue with the da Vinci robotic assisted laparoscopic video while compensating for non-rigid prostate tissue deformation using intra-operative transrectal ultrasound.  The AR will potentially allow surgeons to perform prostatectomies with greatly improved accuracy and possibly lead to improved outcomes and fewer complications.

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NEXPLANON Provides Three Years of Pregnancy Prevention with Simple In-Office Procedure

Merck (MSD outside North America) has announced the availability of the subdermal hormonal contraceptive NEXPLANON 68 mg. This long-acting, progestin-only single-rod hormonal contraceptive is approved by the FDA for pregnancy prevention for up to 3 years. The soft, flexible, matchstick sized polymer is implanted under the skin of a woman’s upper arm with a minor in-office procedure by a healthcare provider. Merck provides clinicians with training on insertion and removal of the device.

NEXPLANON, when inserted correctly, resulted in less than 1 pregnancy per 100 women for 1 year.  The progestin in NEXPLANON, etonogestrel, prevents pregnancy via ovulation inhibition, cervical mucus thickening, and endometrium alterations. After insertion, the device should be palpated to confirm location. It is also radiopaque and thus can be located via different imaging modalities such as X-ray or ultrasound.

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Weil Mini Chest Compressor, a New Product from Resuscitation International

The Weil Mini Chest Compressor, a portable mechanical CPR device by Resuscitation International, is a new product in the fight to battle sudden cardiac death.  It is a pneumatically driven piston device providing optimal chest compressions with adequate strength and depth. The device was developed to be small, easy to deploy, and lightweight. The easy to use design allows for attachment of the device to the patient within 10 seconds.

A torso restraint is placed around the body and easily connected to the piston device allowing for circumferential chest compressions, freeing medical personal to tend to other aspects of handling the patient.

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Cardio Simulator – A Model of Your Heart

Here’s an interesting product known as Cardio Simulator. CrossMedical, based out of Japan, has developed a method to create remarkably precise replicas of the heart using soft materials that reproduce an individual’s heart based on CT data sets.

Using laser fabrication and an epoxy resin a soft detailed model can be created. The company provides pre-made standard adults models or, for a price, one can custom design a model based on CT imaging of a particular patient.  The technology can be used as an educational tool or as part of a pre-op assessment for surgeons to determine which approach is best for the patient, particularly when dealing with congenitally malformed hearts. More information on the process can be found on their website.

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