Posts Tagged ‘INSURANCE’

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BOVIE MEDICAL CORPORATION RECEIVES 510 K CLEARANCES TO MARKET PATENTED J-PLASMA™ TECHNOLOGY

BOVIE MEDICAL CORPORATION RECEIVES 510 K CLEARANCES TO MARKET PATENTED J-PLASMA™ TECHNOLOGY

Bovie Medical received FDA clearance for its J-Plasma handpiece with retractable cutting feature for coagulating soft tissue during surgeries. It is available for both open and laparoscopic procedures.bovie-j-plasma1

The device is powered by a previously approved Bovie GS electrosurgical generator.

J-Plasma™ is formed by passing an inert gas, such as helium, over a sharp conductive point which is held at high voltage and high frequency, producing a luminous discharge beam. The sharp conductive point can also be in the form of a retractable surgical blade, providing multiple modes of operation in a single instrument. The extended surgical blade can be used for incisions and other cutting procedures, and when retracted, the blade is used to form the J-Plasma beam for coagulation. The extended blade can also be used in combination with the J-Plasma beam, providing an enhanced cutting capability with minimal impact on surrounding tissue.

The Company, assisted by leading surgeons, will introduce J-Plasma™ at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year by its independent sales distribution network.

Melville, New York, February 1, 2012 – Bovie Medical Corporation (“Bovie” or the “Company”) (NYSE Amex: BVX), a manufacturer and marketer of electrosurgical products, today announced that the Company received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery. The handpiece will be powered by Bovie’s GS electrosurgical generator, which has prior 510k market clearance.

J-Plasma™ is formed by passing an inert gas, such as helium, over a sharp conductive point which is held at high voltage and high frequency, producing a luminous discharge beam. The sharp conductive point can also be in the form of a retractable surgical blade, providing multiple modes of operation in a single instrument. The extended surgical blade can be used for incisions and other cutting procedures, and when retracted, the blade is used to form the J-Plasma beam for coagulation. The extended blade can also be used in combination with the J-Plasma beam, providing an enhanced cutting capability with minimal impact on surrounding tissue.

The Company, assisted by leading surgeons, will introduce J-Plasma™ at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year by its independent sales distribution network.

Bovie continues to explore and review added applications for J-Plasma™ which include gynecology, dermatology, plastic surgery, infection control, use in robotics and other surgical techniques.

Bovie Medical Corporation CEO Andrew Makrides commented, “This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace.”

Bovie recently announced the granting of a United States patent for a “Method to generate a plasma stream for performing electrosurgery”, adding to the Company’s J-Plasma™ patent portfolio. Bovie has four patents related to its J-Plasma™ technology with three additional patent applications pending.

Cautionary Note on Forward-Looking Statements

Certain matters discussed in this news release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws.  Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.

Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected.  Many of these factors are beyond the Company’s ability to control or predict.  Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this news release can be found in the Company’s filings with the Securities and Exchange Commission including the Company’s Report on Form 10‑K for the year ended December 31, 2010.  For forward-looking statements in this new release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

Source:http://boviemed.com/stocknews.asp#020112

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BattleView Infrared Vascular Trans-illuminator

BattleView Infrared Vascular Trans-illuminator

Let’s just say that you’re a medic out there “in the field” in the middle of the night, with bad guys all over the surrounding hill tops, and they just shot one of your buddies.  You managed to move the injured soldier to a safer location, and are attempting to setup an IV, but you certainly don’t want to turn on the flashlight with enemy snipers scanning every inch of the landscape.BattleView-Infrared-closeup

That’s where the BattleView Infrared Vascular Trans-illuminator may be of help, as it shines infrared light through the body part where you’re trying to set the IV, illuminating the internal anatomy for your night vision goggles to see as bright as day.

From the product page:

The device incorporates four encapsulated IR LED’s that bond with the iron in the venous blood travelling back to the heart, effectively fluorescing the veins.  This makes target veins extremely easy to spot, allowing IV’s to be inserted as if under normal lighting conditions.

BattleView © has a fantastic power to size ratio, capable of shining right through several inches of tissue.  It can be used on the upper appendages to locate commonly targeted veins (Cephalic and Dorsal Venous) in the hand and wrist.  It can even reveal the veins in the medial part of the lower arm (Median Anti-Brachial and Cephalic).  In areas of higher muscular density, BattleView © can be rotated to the same side as the infiltration site to trans-illuminate the superficial target veins.  The same can be done on the lower appendages when targeting common structures like the Saphenous Vein.

BattleView © is one of the most innovative products developed for the tactical medicine community.  Its lightweight foam and neoprene construction make it easily packable in a medic’s kit and it deploys in seconds.  Simply run the patient’s appendage through the shock cord retaining band with the foam pad against the skin and click the on/off button.  BattleView © is powered by a single 3-volt CR123A lithium battery.  The LED’s operate in the near-infrared spectrum.  So, while they mainly produce IR light visible only through night vision goggles, they also emit a faint red glow that is visible to the naked eye.  The red glow can only be seen from a few feet away and is used for checking power status without NVG aid.  The IR emission is very strong, allowing BattleView © to be used as an IR Beacon or area light as well.  In addition, the unit also produces heat when powered on.  The heat lets it be used as a thermal beacon.  Because the device produces heat, though; users should take caution in leaving it on a patient for too long.

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Roswell Park Launches Landmark Immunotherapy Vaccine Trial

Roswell Park Launches Landmark Immunotherapy Vaccine Trial

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) is about to begin a very exciting new cancer clinical trial that will test a personalized immunotherapy to attack cancer cells.

The new NY-ESO-1 dendritic cell vaccine will be produced “using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study,” according to the announcement.

The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

PLEASE NOTE: As expected, Roswell Park Cancer Institute continues to receive a very high volume of calls and emails from patients and their families regarding the vaccine clinical research study that was announced at our press conference, January 24. Many calls and emails (and even some in-person inquiries) are coming into all sectors of the Institute – from the clinics and Switchboard to Patient Access and the Cancer Resource Center. The staff and faculty of Roswell Park are making every effort to ensure that you receive the information you need quickly and efficiently. Therefore, we ask that you ONLY contact the ASK-RPCI information center. To reach the ASK-RPCI information center, call 1-877-ASK-RPCI (1-877-275-7724), Monday through Friday, from 9 a.m. until 5:30 p.m. or send an email to askrpci@roswellpark.org. Information about the trial is also included on the Roswell Park website at www.roswellpark.org. Thank you for both your cooperation and your interest in this important new study.

Dendritic cells are the gatekeepers of the human immune system, defending against invaders like bacteria, viruses and cancer. The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology. Last year, the FDA approved the first therapeutic cancer vaccine, Provenge® (sipuleucel-T), for men with advanced prostate cancer. RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma (a type of brain tumor) and another vaccine for patients with ovarian, fallopian tube, and primary peritoneal cancer.

“This trial will be only the beginning of a very robust program of activity in the area of using the human immune system to fight cancer,” adds Dr. Odunsi. “Our production process holds tremendous potential for applications related to stem-cell therapy and regenerative medicine, and I believe we’re uniquely positioned at RPCI to have the tools, infrastructure and multidisciplinary collaboration to capitalize on these ideas and opportunities both effectively and efficiently.”

The clinical research study will enroll 18-20 eligible patients whose tumors express a specific antigen, known as NY-ESO-1. Apart from the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body, but is expressed in cancers. This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

Dr. Odunsi, who developed the NY-ESO-1 vaccine, led previous trials evaluating its effectiveness in treating ovarian cancer. Christine Sable of Lancaster, Pennsylvania, enrolled on one of those studies in February of 2004, after undergoing surgery and chemotherapy for advanced-stage ovarian cancer. Although she faced a 75-80% chance that the cancer would return, her immune system responded strongly to the vaccine, and she has remained cancer-free in the seven years since then, with no side effects.

Source:http://www.roswellpark.org/media/news/roswell-park-launches-landmark-immunotherapy-vaccine-trial

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Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical has received CE mark approval for its inferior vena cava filter (IVCF) with bi-directional retrieval. Inferior vena cava filters are implanted to trap blood clots that may cause pulmonary embolism in patients who are at high risk but have contraindications to anticoagulation.

The Crux Biomedical IVCF was designed to overcome several limitations of currently available vena cava filters including perforation, migration and inability to retrieve. Features, from the product page:

  • Self-centering – no-tilt symmetrical spiral design centers filter automatically in vessel lumen
  • Bi-directional deployment and retrieval. Twice the retrieval options of other filters. Designed for either jugular or femoral deployment, and retrieval
  • Atraumatic design goal – Tissue anchor lengths optimized for efficient vessel fixation while limiting perforation
  • Total trans-luminal filtration design provides filtration across the entire lumen of the vessel
  • Controlled filter placement via preloaded, low profile, over-the-wire delivery system

MENLO PARK, Calif., Jan. 23, 2012 /PRNewswire/ – Crux Biomedical announced it has received CE mark approval for their revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR).  Vena cava filters are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE).  Each year in the United States, approximately 600,000 patients develop a PE and an estimated 200,000 deaths occur.

The Crux Biomedical IVCF was designed to address the limitations of currently available vena cava filters including perforation, migration and inability to retrieve. “Crux was able to design a device that is both more versatile and simple to use,” stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical.

“We are extremely pleased with the results from the recently completed pivotal trial performed at  22 centers of excellence in the United States, Australia, New Zealand and Belgium. Our device demonstrated an excellent safety profile. The Crux device could be retrieved with a 98% success rate,” stated Mel Schatz, CEO of Crux Biomedical. The Company anticipates submission to the FDA in January and U.S. approval in 2012.

Crux Biomedical is located in Menlo Park, California and is focused on developing improved therapies for the human vasculature. It is funded by Alloy Ventures, Three Arch Partners, Emergent Medical Partners and Thomas Fogarty, M.D.. Additional information is available at www.cruxbiomedical.com.

Source:http://www.prnewswire.com/news-releases/crux-biomedicals-ivc-filter-receives-ce-mark-approval-137876098.html

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Microsulis Medical’s ablation device used in first microwave assisted robotic liver resection

Microsulis Medical’s ablation device used in first microwave assisted robotic liver resection

Microsulis Medical is reporting that its Acculis microwave thermal ablation system has been successfully integrated with the da Vinci robotic surgical system and used to perform a minimally invasive hepatectomy.

The Acculis Accu2i pMTA applicator delivers microwave energy at 2.45 GHz while pumping cooling fluid through the applicator needle to keep the device within operating temperatures.acculis-accu2i-applicator

Some details about the procedure:

The patient, a 60-year-old female, presented with a liver lesion measuring 3.5cm. Dr Legaspi used the da Vinci’s state-of-the-art robotic technology to operate through tiny incisions in the patient’s abdomen. Using intra-operative ultrasound and direct visual guidance he located the target coagulation zones and used the da Vinci system to place the Accu2i pMTA along the line he intended to cut in order to minimise blood loss. In total he conducted six 120 watt, two minute burns.

Dr Legaspi then proceeded to cut out the lesion with minimal blood loss while carrying out three further two minute burns at 180 watts. At the end of the operation the removed tissue measured approximately 5.5cm, providing an excellent margin, and the collection canister was empty, with only trace amounts of blood in the suction tubing. In total, the patient was in theatre for two and half hours.

Microsulis is a medical device developer specialising in minimally invasive microwave technology for the coagulation, or destruction, of soft tissue. Clinicians have successfully used the company’s devices to coagulate tissue in the liver, lung, kidney and bone.
The recent hepatectomy involving the da Vinci Surgical System and Accu2i pMTA was carried out by Dr Adrian Legaspi, MD, at Mount Sinai Medical Center, Florida.
The patient, a 60-year-old female, presented with a liver lesion measuring 3.5cm. Dr Legaspi used the da Vinci’s state-of-the-art robotic technology to operate through tiny incisions in the patient’s abdomen. Using intra-operative ultrasound and direct visual guidance he located the target coagulation zones and used the da Vinci system to place the Accu2i pMTA along the line he intended to cut in order to minimise blood loss. In total he conducted six 120 watt, two minute burns.
Dr Legaspi then proceeded to cut out the lesion with minimal blood loss while carrying out three further two minute burns at 180 watts. At the end of the operation the removed tissue measured approximately 5.5cm, providing an excellent margin, and the collection canister was empty, with only trace amounts of blood in the suction tubing. In total, the patient was in theatre for two and half hours.
After the case Dr Legaspi said: “I feel that the capability of pre-coagulation with microwave ablation for robotic surgery is going to help reduce operative time and improve patient outcomes.”
Stuart McIntyre, Chief Executive of Microsulis Medical Ltd, said: “We are delighted that the versatility of the Accu2i pMTA applicator has been highlighted as part of this technologically advanced, minimally invasive procedure.”
The Accu2i pMTA applicator – part of the Acculis Microwave Tissue Ablation (MTA) system – is the most powerful soft tissue ablation product available, combining extreme ease of use with the widest range of clinical applications. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. It can coagulate tissue masses of up to 5.6cm in size in just six minutes.
Mount Sinai Medical Center is the largest private independent teaching hospital in South Florida and has used Microsulis Medical’s Acculis MTA system since April 2011.
Dr Legaspi is working on a full write up of this liver resection case for publication in the near future.
Microsulis’ microwave tissue ablation devices have been used in more than 100 hospitals world-wide.

Source:http://medgadget.com/2011/12/microsulis-microwave-thermal-ablation-system-now-used-in-robotic-liver-resection.html,http://www.microsulis.com/content.php?page=news&i=72.

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Infra-scanner; Quick, Cheap & Easy Bedside Diagnosis of Brain Injury

Infra-scanner; Quick, Cheap & Easy Bedside Diagnosis of Brain Injury

Intuitive Surgical received FDA clearance and will be making available its Single-Site Instrumentation for performing laparoscopic robotic-assisted cholecystectomies.

The kit is used with the da Vinci Si robotic surgical system much like traditional multi-port surgeries, providing surgeons precise control and 3D high definition video at the console.  infrascanner-brain-diagnostics

Infrascanner™ is a hand-held, non-invasive, near-infrared (NIR) based mobile imaging device to detect brain hematoma at the site of injury within the “golden hour”. This refers to the period following head trauma when pre-hospital analysis is needed to rapidly assess the neurological condition of a victim.

The InfraScanner™ can be a practical solution to the problem of early identification of intracranial hematomas because of the unique light-absorbing properties of hemoglobin and the non-invasive, non-ionizing nature of NIR technology. The basic method for Hematoma detection is based on the differential light absorption of the injured vs. the non-injured part of brain. Under normal circumstances, the brain’s absorption should be symmetrical. When additional underlying extra vascular blood is present due to internal bleeding, there is a greater local concentration of hemoglobin and consequently the absorbance of the light is greater while the reflected component is commensurately less. This differential can be detected via sources and detectors placed on symmetrical lobes of the skull. The science of diffused optical tomography used by the Infrascanner™ enables the conversion of light differential data into interpretative scientific results. The Infrascanner™ unit is a small, portable handheld device based on a PDA platform with wireless detector probes.

The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

The device, called the Infrascanner Model 1000, can help health care providers identify patients with critical head injuries who need an immediate brain imaging study.

Intracranial hematomas occur when blood from a ruptured blood vessel collects within the brain or between the skull and the brain. As blood expands within the brain or in the narrow space between the brain and the skull, the brain becomes compressed. This can produce symptoms such as headaches, vomiting, dizziness, lethargy, weakness in the arm or leg on one side of the body, seizures, or unconsciousness. An intracranial hematoma can be life-threatening if it is not treated immediately.

The Infrascanner, Model 1000, uses a scanner that directs near-infrared light, a wavelength of light that can penetrate tissue and bone, into the skull. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption (optical density) and transmits the information wirelessly to a display on a hand-held computer.

By comparing the optical density from a series of scans of specific areas on both sides of the skull, a trained health care provider can use the information provided by the device, in conjunction with other clinical information, to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures, such as a computed tomography (CT) scan.

The FDA granted the de novo petition for the Infrascanner Model 1000 based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan.

The FDA is specifying special controls in an accompanying regulation classifying the Infrascanner Model 1000 as a Class II device with special controls. The special controls provide information about specific risks that must be addressed by other manufacturers who may wish to market a similar device. The Infra-scanner Model 1000 is manufactured by InfraScan Inc. of Philadelphia.

Source:http://medgadget.com/2011/12/infrascanner-looks-for-bleeding-in-brain-injury-victims.html, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm283520.htm

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FDA Clears Hologic’s Specimen Radiography System

FDA Clears Hologic’s Specimen Radiography System

The new system is self-contained and eliminates the need for samples to be taken to the radiology department for X-ray imaging. Performing the verification in the same room as or within close proximity from the procedure improves workflow, thus reducing procedure time for the patient. The Trident system’s selenium-based detector, with its 12 cm...

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ZEN Results Raise Early Hopes For DES In Erectile Dysfunction

ZEN Results Raise Early Hopes For DES In Erectile Dysfunction

Thirty-day and three-month results from an eagerly awaited first trial to test a drug-eluting stent (DES) for the treatment of erectile dysfunction suggest that this novel use for a DES is safe and associated with significant improvement in erectile function and satisfaction. But the trial also encountered logistical problems related to the uncharted complex terrain of the pelvic vasculature, meaning that the next trial in this arena is going to take a step back.

Medtronic released preliminary study data concluding that their drug-eluting stents help men with erectile dysfunction who do not respond to treatment with drugs. The medical device giant conducted a study in 30 men and the results of the first three months were reported by Dr. Jason Rogers of UC Davis Medical Center at the VIVA 11 conference in Las Vegas this week.

The zotarolimus coated stents were placed into the internal pudendal artery, which accounts for the blood supply to the penis. This intervention opened the blood vessel and improved blood flow towards the penis. The treated men showed improvements on the Index of Erectile Dysfunction scale and there were no adverse events. Most important: the treated men were excited and happy with the treatment and its effects. Ultrasound tests also confirmed that the blood flow improved significantly after the placement of the stent at the beginning of the study.

Dr. Rogers announced that a new trial will be launched to investigate the pelvic anatomy using angiography in men with and without erectile dysfunction. The trial will not involve stenting. This is to better understand how the stents led to such an improvement, and how they can be safely delivered. Rogers also stated it could be several years before Medtronic undertakes a much larger late-stage trial. It will be interesting to see whether this newly arisen technique will be able to keep standing in the combat against erectile dysfunction.

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Canon TX-20 Full Auto Tonometer Receives FDA Clearance

Canon TX-20 Full Auto Tonometer Receives FDA Clearance

Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions. With more than $45 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks fourth overall in patent holdings in the U.S. in 2010†, and is one of Fortune Magazine’s World’s Most Admired Companies in 2011. Canon U.S.A. is committed to the highest levels of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes.Medical technology

Canon has received FDA 510(k) clearance for the TX-20 full-auto non-contact tonometer. The device can be used with a touch of one button when in fully automatic mode, or a peak intraocular pressure (IOP) can be set so that the device issues a warning message when that pressure is reached.

From the press release: If a high IOP is detected, a warning message is displayed. The operator can enter any threshold value on the unit’s settings screen to activate the warning system for that value. When in Full Auto mode, the TX-20 Tonometer is a one-touch operation for IOP measurement of both eyes. With one press of the start button, the unit automatically aligns and measures the intraocular pressure of both eyes. The compact and lightweight TX-20 Tonometer weighs approximately 33 pounds and comfortably fits on an instrument table with a Canon Non-Mydriatic Retinal Camera (each sold separately). Keeping the Canon ophthalmic units next to one another can help to expedite the exam process.

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Mayo Clinic Researchers Use Human Vaccine To Cure Prostate Cancer In Mice

Mayo Clinic Researchers Use Human Vaccine To Cure Prostate Cancer In Mice

Mayo Clinic investigators and collaborators from the United Kingdom cured well-established prostate tumors in mice using a human vaccine with no apparent side effects. This novel cancer treatment approach encourages the immune system to rid itself of prostate tumors without assistance from toxic chemotherapies and radiation treatments. Such a treatment model could some day help people to live tumor free with fewer side effects than those experienced from current therapies.

The findings appear in the journal Nature Medicine.

“We are hopeful that this will overcome some of the major hurdles which we have seen with immunotherapy cancer research,” says Richard Vile, Ph.D., Mayo Clinic immunologist, Richard M. Schulze Family Foundation Professor and a lead author of the study. Clinical trials could begin within two years.

Mayo’s immunotherapy research led by Dr. Vile already shows promise in treating prostate cancer and melanoma. It also is a prime candidate for treatment of many more aggressive cancers, such as lung, brain and pancreatic cancer.

Among the team’s findings: no trace of autoimmune diseases in the mice. The murine T-cells attacked only cancerous prostate cells, leaving the healthy tissue unharmed.

To develop this new approach, geneticists assembled snippets of genetic code from healthy human prostate tissue into a complementary DNA (cDNA) library. These bits of cDNA were then inserted into a swarm of vesicular stomatitis viruses (VSV), which were cultured and reintroduced into the test mice as a vaccine during a series of intravenous injections.

Development of comprehensive cDNA libraries from healthy human prostate tissue represents the key to successful immunotherapy. All infections, allergens and tissues, including tumors, have a unique fingerprint called an antigen – a molecular protein tag that triggers a response from the body’s immune system. Dr. Vile deployed the human vaccine prostate cancer antigens through the mutated VSV vector to raise a full-on assault from the mice’s T-cells. After exposure to the mutated viruses, the animals’ immune systems recognized the antigens expressed in the virus and produced a potent immune response to attack the prostate tumors.

“Nobody really knows how many antigens the immune system can really see on tumor cells,” says Dr. Vile. “By expressing all of these proteins in highly immunogenic viruses, we increased their visibility to the immune system. The immune system now thinks it is being invaded by the viruses, which are expressing cancer-related antigens that should be eliminated.”

Previous attempts to vaccinate against prostate and other types of cancerous tumors have been hampered largely by researchers’ inability to isolate a sufficiently diverse and robust collection of antigens in tumor cells. Because of this, tumors often mutate and re-establish themselves in spite of the body’s immune system.

The use of viruses as vectors for cDNA libraries overcomes the difficulty of isolating antigens in tumor cells by giving the immune system a more complete picture of the cancerous invader

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