CardioFocus Studies Visually Guided Laser Ablation

CardioFocus explored visually guided laser ablation in recent clinical research as a single-centre long-term experience. The researched revealed single-centre experience incorporating VGLA over four years can be safely applied in clinical practice with effective results. The research demonstrated high levels of acute PVI together with positive, long-term clinical outcomes.

The study was conducted with one hundred and ninety-four patients who suffered a medical history of drug-refractory PAF or recurrent AF. CardioFocus administered treatment in their laboratory with VGLA between over the course of four years. The single-center VGLA treatment demonstrated high levels of effectivity.

Hopkins Joins Summit Technology

Summit Technology recently announced its new Senior Vice President, Robert Hopkins. Mr. Hopkins joined Summit Technology in May. His role is to foster growth in the Northeast. Mr. Hopkins has more than twenty years of industry experience. Previous to  working with Summit Technology, Mr. Hopkins played a lead role at Oracle, Ceridian, ADP, CenturyLink, and AT&T. Mr. Hopkins is a professional known for his innovative approach to sales. Mr. Hopkins holds a Bachelor of Science in Management from the Quinnipiac University.

Syneron Candela Reveals Larsa Pippen As Latest UltraShape Brand Ambassador

Syneron-Candela, an international leader in cosmetic medical devices, announced that Larsa Pippen is the newest brand ambassador for its chief product, UltraShape. Larsa Pippen is best known for her role in TV show Real Housewives of Miami. Pippen is also the wife of six-time world champion NBA star, Scottie Pippen.

Ultrashape, a noninvasive medical device for the treatment of excessive abdominal fat, is reported to potentially offer results as soon as two weeks after the initial treatment. Syneron-Candela recommends patients undergo at minimum of three or more treatments for optimal effects.

“UltraShape gives me more confidence. I eat well and exercise regularly, but as a mom of four, there are certain areas that are resistant to all my efforts,” Larsa Pippen said at a recent press conference in New York City.

Syneron-Candela, founded in 2000, is headquartered in Israel. The global cosmetic medical device company currently markets its products in 86 countries. Syneron-Candela has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.

TMS Therapy Presented at World Congress of Biological Psychiatry

Transcranial Magnetic Stimulation (TMS), the flagship medical device by NeuroStar, has been demonstrated to effectively reduce major depressive symptoms during pregnancy. TMS Therapy offers a safe and effective alternative to pharmaceutical antidepressants to women who choose to abstain from traditional pharmaceuticals. The results of a recent study were presented at the 12th World Congress of Biological Psychiatry earlier this month.

The study observed 22 women with major depressive disorder, who ranged from 14 to 34 weeks in gestation. The study treated 12 patients with active TMS and another 10 treated with a placebo.

The patients receiving the TMS therapy were given 20 sessions of right-sided TMS delivered to the dorsolateral prefrontal cortex at a dose of 1 Hz in a 15-minute train at 100% motor threshold (900 pulses/session), while the other group received a placebo that was administered by mimicking the first group’s, real treatment.

While the left-side is the traditional location for TMS to be administered, investigators selected the right-side to minimize any risk for seizure. If seizure does occur in pregnancy, it can result in fetal death.

At the end of treatment, 75% of women who received who received active TMS therapy responded to treatment at the end of the 20-session protocol, while only 50% of women given the placebo responded.

“Neither progesterone nor any other levels of female hormones were different between the two groups, so we are not doing anything systemically to these women when they undergo TMS. Otherwise, they would not be able to have a successful pregnancy,” said study investigator Deborah Kim, MD, assistant professor of psychiatry, University of Pennsylvania, in Philadelphia.

Adverse events from the magnetic effect from TMS would not be expected, said Dr Kim, because the magnet only influences a 2×2-cm area of the cortex and so comes nowhere near the uterus.

“This is really an acceptability issue,” said Dr. Kim. “Women will say that they prefer psychotherapy over medication, but access to psychotherapy and its cost limit its use, and the fact that not everybody responds to psychotherapy means we need something else,” she said.

FDA Approves Portable Cardio Ultrasound

The Food and Drug Administration has approved a cardiac ultrasound system, created by CardioNexus Corp., for the early detection of heart disease.

The potable system uses an ultrasound system for non-invasive heart examinations ouside of an office or clinic setting, and enables physicians to detect arterial plaque and to measure arterial wall thickness.

For more information see this article: <a href=””>CardioNexus nabs FDA approval for heart device | Houston Business Journal</a>

Aspirin, Simvastatin Provide No Benefit for PAH: Study

Taking aspirin or simvastatin does not appear to benefit those with pulmonary arterial hypertension (PAH), according to recently published research.

Researchers from the University of Pennsylvania School of Medicine conducted a study with 65 patients with PAH who had been randomized into four groups: those taking aspirin, simvastatin, aspirin plus simvastatin, or neither.

The investigators used a six-minute walk distance (6MWD) as the key outcome measure in the study, and found that the 6MWD tended to be lower among those taking simvastatin at six months.

The investigators also found no significant difference in the 6MWD between those who received aspirin and those who received placebo. The results of this study do not support the routine treatment of PAH with aspirin or simvastatin.

The research was published in Circulation, coinciding with a presentation at the American Thoracic Society’s 2011 International Conference in Denver.

For more information:

NWBT, Fraunhofer Partner to Produce DCVax

Northwest Biotherapeutics and Fraunhofer have announced that they are partnering to produce DCVax®-L for brain cancer for both clinical trials and compassionate use cases in Europe.

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis.

Fraunhofer — a highly respected leader in many areas of technology, including cell and immune therapies — is the largest applied research foundation in Europe.  The company has a staff of more than 18,000 scientists, engineers, and business personnel dedicated to practical applications and commercialization of research results.

The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in Leipzig, Germany, has dedicated a substantial portion of its state-of-the-art manufacturing facilities to the production of DCVax®, and is assisting NWBT with the applicable regulatory requirements for both clinical trials and compassionate use cases.

The partnership will enable NWBT to advance clinical trials in Europe, and to provide compassionate use treatments of patients along with clinical trials.

For additional information:

Neuronetics, Inc. Completes Series E Financing for $30 Million

Neuronetics, Inc. has announced that it has completed its Series E financing totaling $30 million, with two new investors — Polaris Venture Partners and Pfizer Venture Investments — leading the round.

Neuronetics, Inc. is the maker of the NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy® System for the treatment of major depression. Investor Growth Capital, New Leaf Venture Partners, Interwest Partners, Three Arch Partners, Quaker BioVentures, and Onset Ventures are previous investors who participated in the round.

Neuronetics has marketed the NeuroStar TMS system for the treatment of major depression for patients who have not adequately benefitted from prior antidepressant medication.  The therapy system was cleared by the United States Food and Drug Administration in October 2008.

“This financing is a tremendous vote of confidence in the potential of NeuroStar TMS Therapy by two premier life science investors,” said Bruce J. Shook, President and CEO of Neuronetics, Inc. “The financial resources, experience and knowledge that Polaris and Pfizer bring to our company will allow us to build on our success and accelerate our efforts to bring NeuroStar to the millions of people suffering from depression.”

“The market opportunity for a novel, non-invasive and non-systemic treatment for major depression like Neuronetics’ NeuroStar TMS Therapy is extremely attractive,” said Kevin Bitterman, Ph.D., Principal at Polaris Venture Partners. “The NeuroStar TMS system gives psychiatrists an entirely new tool in their effort to treat those patients who are struggling with depression and do not get relief from existing therapies. The team at Neuronetics has done an impressive job of bringing this technology into mainstream medical practice, and we look forward to helping advance this important effort.”

“Pfizer has had a longstanding interest in treating depression,” said Elaine Jones of Pfizer Venture Investments. “We look at Neuronetics’ progress as the beginning of a potentially important advance in how we treat this often debilitating, chronic and costly disease. We are excited about supporting Neuronetics’ effort to bring a new and innovative solution to psychiatry.”

Neuronetics, Inc. is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic-field pulses. Based in Malvern, Penn., Neuronetics is the leader in the development of NeuroStar TMS Therapy, a non-invasive and non-systemic form of neuromodulation. Neuronetics, Inc. was represented in the Series E financing by Pepper Hamilton, LLP.

For additional information:

New Research on Neurodevelopmental Outcomes of Children with CHD

Researchers from the Cardiac Center at The Children’s Hospital of Philadelphia have found that children with congenital heart defects (CHD) who receive heart surgery in infancy experience better neurodevelopmental outcomes at age four when born closer to term. Better outcomes were found in infants born after 39 weeks versus infants born at 36 to 38 weeks.

Concerns over maternal and fetal health often prompt early delivery of children with CHD. When health concerns are not present, this research suggests that elective or spontaneous delivery at 39-40 weeks is preferable as it is associated with better neurodevelopmental outcomes.

The researchers analyzed a total of 351 infants born at 36 weeks gestation or later that were enrolled in a study for apolipoprotein-E (APOE) polymorphisms and neurodevelopmental outcome after infant cardiac surgery. Formal neurodevelopmental testing was performed at four years of age, including tests for attention, impulsivity, memory, cognition, language skills, executive function, social competence and visual-motor and fine-motor skills.

The median gestational age was 39 weeks with 125 patients born at 40 weeks or older. Older gestational age predicted better performance for short and long-term outcomes including cognition, visual-motor and fine-motor skills.

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Cryoballon-Based Technology Treats Atrial Fibrillation

Medtronic, based in Minneapolis, recently announced that its cardiac catheter system, Arctic Front, the first cryoballon-based technology treatment for a common type of irregular heartbeat, was approved by Health Canada.

Cryoballon technology uses a coolant delivered through a catheter to block atrial fibrillation, a common arrhythmia.  The minimally-invasive procedure creates circumferential lesions around the pulmonary vein, which can cause an irregular heartbeat through erratic electrical signals. The cooling technology allows the catheter to adhere to the tissue, and this leads to increased stability.

Health Canada approved the treatment based on a study demonstrating that 69.9% of patients treated with the system were free from atrial fibrillation at one year, compared to only 7.3% of patients who were free from atrial fibrillation at one year after treatment with drug therapy.

Half of all diagnosed atrial fibrillation patients fail drug therapy, according to recent research.  If atrial fibrillation is left untreated, patients have up to a five times higher risk of stroke and an increased chance of developing heart failure.

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