The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s article comes from the Cardiovascular Device Business Newsletter from Espicom Business Intelligence.

VentriPoint Diagnostics has met with the FDA to review its plans for the clinical trial and regulatory submission for the first application of the VMS heart analysis system for the congenital heart disease known as Tetralogy of Fallot. The FDA informed the company it had answered all its questions and addressed all of the earlier observations pertaining to the trial, paving the way for the start of the trial in the US.

The Tetralogy of Fallot study has begun in the US and is designed to show substantial equivalency between the gold-standard, MRI method and VentriPoint’s 2D-ultrasound, VMS technique. Based on advice from the FDA, the study has been designed to collect images at multiple sites and to analyse them in core labs. Nationwide Hospital in Columbus, OH is the lead centre for the study and the University of Nebraska has been named as a second site. A number of other clinical sites are expected to join the study. Nationwide Hospital has also been selected as the core lab for the analysis of MRI studies and the Hospital for Sick Children in Toronto, Canada has been selected to carry out all the analyses of the studies.

To date, 20 patients have been enrolled in the study and a total of 75 evaluable cases are required for study completion. VentriPoint anticipates enrolment will accelerate as the other centres become operational. The data collection should be completed this spring and a response from the FDA is anticipated this summer, depending on the rate or recruitment by existing and new centres.

VentriPoint estimates the market for product for Tetralogy of Fallot to be US$200 million and is already marketing the device in Europe and Canada, where it is approved for clinical use. The company has a target of placing 50 VMS devices in 2012 and anticipates that sales will increase rapidly during 2012 should FDA approval for Tetralogy of Fallow is achieved and approval for pulmonary hypertension is received in Europe and Canada.

The pulmonary arterial hypertension application is expected to over lap with the US congenital heart disease programme. A clinical evaluation of the pulmonary arterial hypertension application has already begun at the University of Chicago. This should be complete in a few weeks and, if successful, VentriPonit will use the data to file for CE mark and Canadian approval marketing applications. A number of medical centres have agreed to be part of this pivotal trial. Based on experience with the Tetralogy of Fallot trial, the company has already started the IRB and budget-approval processes with these major cardiovascular centres, as this is the most time-consuming part of the process. The sites will be selected shortly and will become operational as soon as possible.

Much of 2011 has been spent upgrading both hardware and software based on the feedback from the users and developing new applications such as pulmonary hypertension. The latest software, version 1.1, is completed and undergoing final testing. The major hardware feature expansion is the ability to interface with the newer digital ultrasound machines, which the company says is likely to  take over the market in the next five years. A key software enhancement is the ability to export VMS studies to the hospital PACS, enabling third party DICOM viewers to review the VMS results. Existing sites will be updated remotely with the new version as soon as it has been released for general use.

Looking ahead, VentriPoint is actively seeking partnerships with large manufacturers of ultrasound equipment for combination products and distribution. The company says there is considerable interest in developing a stand-alone system for pulmonary hypertension, as this would be a completely new application for ultrasound.

Article source: Lawrence Miller, editor Cardiovascular Device Business, and medical newsletters team leader at Espicom Business Intelligence

Espicom Business Intelligence

Pathwork tissue of origin test confirms clinical validity

The Medical Technology Blog

Independent study of Pathwork tissue of origin test confirms clinical validity; “cost-effective for increasing cancer patient survival”

Results of a study conducted at Virginia Commonwealth University of the Pathwork Diagnostics’ Pathwork tissue of origin test have been published online in the American Journal of Clinical Pathology, in a paper entitled “Clinical verification of the performance of the Pathwork tissue of origin test: utility and limitations”. The Pathwork tissue of origin test is an FDA-cleared, Medicare-covered molecular diagnostic for identifying tissue of origin. It uses a tumour’s own genomic information to help pathologists and oncologists in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history.

In the study, the analytic and clinical performance of the tissue of origin test was examined in 43 poorly differentiated and undifferentiated tumour samples. Results showed 97 per cent (95 per cent confidence interval, 80.4 to 99.8 per cent) agreement between the tissue of origin test result and the reference diagnosis, which was determined on the basis of clinical correlations and immunohistochemical findings and was among the 15 tumour tissue types covered by the tissue of origin test.

The Pathwork tissue of origin test measures gene expression levels of 2,000 genes and uses algorithms to compare the tumour’s gene expression pattern with that of 15 tumour types, representing 58 morphologies and 90 per cent of all solid tumours. The test provides objective genomic information to help the physician diagnose what type of cancer the patient has. An accurate diagnosis allows oncologists to match therapy to the cancer.

In a related development, results from a study involving the Pathwork tissue of origin test have been presented at the American Association for Cancer Research – International Association for the Study of Lung Cancer joint conference on The Molecular Origins of Lung Cancer: Biology, Therapy and Personalised Medicine in San Diego, CA. The study, “Cost-effectiveness of gene-expression profiling for tumour-site origin”, was authored by John Hornberger, Irina Degtiar, Hialy Gutierrez, Ashwini Shewade, W David Henner, Shawn Becker and Stephen Raab.

The retrospective, observational study examined treatment changes made in patients by physicians who received tissue of origin test results. Changes in planned chemotherapy, surgery, radiation therapy, blood tests, imaging and referral to hospice care before and after test results were recorded. Estimates of the effect of changes in chemotherapy on survival were based on National Comprehensive Cancer Network (NCCN) and other treatment guidelines. Costs were estimated based on data from NCCN and Centers for Medicare and Medicaid Services fee schedules. Changes in overall survival, costs and cost per quality-adjusted life year (QALY) gained were estimated. In the study, use of chemotherapy regimens consistent with guidelines for the final tumour-site diagnosis increased from 42 per cent to 65 per cent. Overall survival was projected to increase from 15.9 months to 19.5 months, a mean gain of 3.6 months. The average increase in survival adjusted for quality of life was 2.7 months and the average cost per QALY gained was US$46,858.

Article source; Diagnostics Focus, edited by Sophie Bracken, medical news editor at Espicom Business Intelligence.


Mouse here for
Related Links

Espicom Business Intelligence

Alexza Pharmaceuticals Issue Job Warning

The Medical Technology Blog

Alexza employees face the chop in company bid to prop up Adasuve development

Drug Delivery Insight

In an effort to save cash in the current economic downturn, Alexza Pharmaceuticals has made the difficult decision to appoint a financial advisor to assist in exploring strategic options for the company. These options could include a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions. In order to conserve cash needed to support operations, Alexza has provided to all of its employees a 60-day notice of layoffs under the California WARN Act. The company expects to significantly reduce its workforce as it continues the actions necessary to pursue FDA approval of Adasuve (Staccato loxapine) and continues its MAA work with the EMA.

Recently, the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted to recommend that Adasuve be approved for use as a single dose in 24 hours in conjunction with the FDA recommended REMS, for the treatment of agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain). The PDAC also concluded that the product had been shown to be effective (vote of 17/1/0; yes/no/abstain), and that the product would be acceptably safe for use as a single dose in 24 hours, when used in conjunction with the REMS proposed by the FDA (vote of 11/5/2; yes/no/abstain). The Adasuve NDA has a PDUFA goal date of 4th February 2012.

Adasuve is an anti-agitation product candidate that combines Alexza’s Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable with intravenous administration. In clinical studies, Adasuve has shown an onset of effect in ten minutes of dosing, which is the first time point measured in Phase III studies.

Article source; Kindly provided by Sophie Bracken, editor of Espicom’s business publication Drug Delivery Insight

Espicom Business Intelligence

Gilead submits sNDA for Truvada for reducing the risk of acquiring HIV

The Medical Technology Blog

Gilead Sciences Truvada

Gilead Sciences has submitted an sNDA application for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the US.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The application is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the National Institutes of Health (NIH) and the University of Washington.

The first trial providing data to support the Truvada sNDA is a Phase III, randomised, double-blind, placebo-controlled trial known as the Pre-Exposure Prophylaxis Initiative (iPrEx), which was sponsored by the NIH and conducted among 2,499 high-risk HIV-negative adult homosexuals in the US and countries in Africa, Asia and South America. Results from the trial, published in the New England Journal of Medicine in November 2010, showed that once-daily use of Truvada for PrEP reduced the risk of acquiring HIV overall by 44 per cent compared with placebo and by up to 73 per cent among men who reported taking the drug consistently (defined as at least 90 per cent of days). Among men who took the drug consistently enough to have detectable drug in their body, the risk was reduced by more than 90 per cent.

The Truvada sNDA submission is also supported by data from Partners PrEP, a Phase III, randomised, double-blind, placebo-controlled trial conducted among 4,758 heterosexual couples in Kenya and Uganda, in which one partner was infected with HIV and the other was not. The trial, sponsored by the University of Washington, showed that once-daily use of oral Truvada by the HIV-negative participants reduced their risk of acquiring HIV by 73 per cent compared with placebo.

Additional supportive data come from two studies sponsored by the Centers for Disease Control (CDC). The first trial, known as TDF2, was a Phase III, randomised, double-blind, placebo-controlled trial conducted in Botswana among 1,200 HIV-negative heterosexual men and women. Participants taking once-daily oral Truvada for PrEP had 63 per cent fewer HIV infections compared with those receiving placebo. The second trial, known as CDC 4323, was a Phase II, randomised, placebo-controlled, double-blind study of homosexual men in the US primarily designed to assess the safety, adherence and acceptability of PrEP.

Although full details are not yet available, another separate Phase III study of Truvada for PrEP known as FEM-PrEP was stopped in April 2011 based on a recommendation by the study’s Independent Data Monitoring Committee that the trial would not be able to establish the efficacy of Truvada among HIV-negative women in sub-Saharan Africa. The reason for this outcome is not yet understood and a complete detailed analysis of the data is currently under way.

In all studies, side-effects included nausea, weight loss and serum creatinine elevations. The incidence of side effects was consistent with Truvada’s safety and tolerability profile when used as HIV treatment, which is supported by more than 1.8 million years of patient use. Overall, there have been more than 4.4 million patient years of experience with tenofovir-containing regimens. Three cases of resistance to emtricitabine were reported in the iPrEx trial among participants who tested negative for HIV infection by serology at enrollment, but were later found to have been infected with HIV prior to enrolment using a different assay. Two of these cases occurred in the active drug arm, and one case occurred in the placebo arm.

For more articles like this, start your subscription today to Drug Delivery Insight


Espicom Business Intelligence

French Breast Implants Scare

The Medical Technology Blog

Breast implants safety thrown into question as France makes precautionary move to remove controversial PIP implants from patients

Just when the breast implant industry was getting some kind of good safety record, the death of a woman in France who had been implanted with an implant made by the French company, Poly Implants Protheses (PIP) has re-ignited the debate about the safety of the devices.

There’s no doubt the breast implant industry has worked hard to restore its image and relevance since the dark days of the 1980s when the embryonic industry was dogged by safety concerns and mass litigation. However, the spectre of safety has never really gone away completely. Last year, PIP had its breast implants banned after they were found to include a non-medical grade silicone filler. The issue has rumbled on quietly all year in Europe, but has been reignited following the death of a woman implanted in France with a PIP breast implant has been now been associated with an anaplastic large cell lymphoma (ALCL), a rare form of cancer which affects cells of the immune system.

The UK MHRA, in a bid to calm nerves, has pointed out that there is currently no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority is also consistent with consultations it has made with experts in the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta, in terms of rupture events. There has also been no reported cases of lymphoma.

Despite that, authorities in France have recommended that 30,000 women in the country have their faulty breast implants removed as a precautionary measure. The French government, which still says there is no evidence of a cancer link, plans to cover the financial cost. Media reports suggest around 40,000 women in the UK have the implants and the conflicting signals arising from the two countries makes it a very uncertain time for those who have undergone breast implants, let alone those who have directly used PIP implants.
The UK viewpoint basically seems to urge woman to sit tight and discuss the issue with their doctors. Data wise, the agency has a point. The MHRA points out that approximately 1 per cent of women in the UK with PIP breast implants have suffered implant failure, including rupture. This contrasts with information from the French medical device regulatory authority, AFSSAPS, which suggests a failure rate, including rupture, of around 5 per cent in France. It doesn’t go far as trying to explain the reasons behind this anomaly, which doesn’t provide too much consolation.

From an industry perspective, it means the industry is back in the doghouse in terms of respectability. In the US, the FDA hasn’t been spent most of this year formulating plans to tighten up the implant regulatory process even more, with the result that companies are likely to face even more scrutiny than ever. Of course, the social cost makes these responses entirely natural, and agencies cannot fail to acknowledge the issues out there, but it looks like the start of difficult times for the breast implant industry in 2012 unless they can meet these challenges and prove, once and for all, that these implants are effective and safe options for women.

Article source: Article kindly provided by Lawrence Miller, editor of Espicom’s business publication Medical Industry Week, and editor-in-chief of the medical newsletters team.

Espicom Business Intelligence

Espicom Predicts the Global Telemonitoring Market Could Exceed US$1 Billion by 2015

The Medical Technology Blog

Rising rates of chronic disease are pushing healthcare providers into seeking better and more-cost-effective ways of delivering care. Telemonitoring technology has great promise but has yet to be widely implemented, and the early results reveal significant operational obstacles which must be overcome in the medium term if it is to reach its full commercial potential.

The Global Telemonitoring Market graph

The Global Telemonitoring Market, 2010-2016E (US$ million)

According to a new Espicom report, Telemonitoring: Challenges & Opportunities, the global telemonitoring market could be set for rapid growth, driven by the world’s ageing population and increasingly unhealthy lifestyles, which are leading more and more people to need care for chronic diseases.

Interest in telemonitoring is on the rise due to its potential to improve the health of patients with chronic diseases, enable people to receive care in the comfort of their own home and reduce the number of patients that have to been seen in doctors’ surgeries. With the World Health Organization estimating that chronic diseases now account for twice as many deaths as communicable diseases, including HIV/AIDS, TB and malaria, and predicting that deaths due to chronic disease will increase by 17% over the next 10 years, the need to effectively manage these conditions has never been more pressing. The global economic downturn and reduced healthcare budgets are also leading healthcare managers to look to telemonitoring as a way of “doing more for less”.

Although telemonitoring holds much promise, there are several issues that are hindering its adoption. The technology has not been shown conclusively to improve care or reduce costs and it doesn’t yet have broad reimbursement coverage. More importantly, it requires healthcare providers to change working practices and realign healthcare budgets, while patients have to want to be actively involved in their healthcare for it to work.

Telemonitoring lets doctors monitor a patient’s health while the patient is at home, collecting vital signs data and information on current symptoms, medication, diet and exercise. It alerts healthcare providers if a patient’s health is deteriorating so that action can be taken. The technology can be used for any disease where doctors need to keep a regular check on patients, including heart failure, hypertension, diabetes and respiratory diseases, as well as patients with a combination of diseases.

Joanne Maddox, senior health analyst at Espicom and the report’s author comments “…for the industry to capitalise on the growing interest in telemonitoring, there needs to be a focus on gathering clinical data that show the technology is both clinically and cost-effective. This will help to convince healthcare providers of its usefulness and pave the way for reimbursement”.

For further information on the report please visit Telemonitoring: Challenges & Opportunities

Espicom Business Intelligence
The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s post is taken for Espicom’s business publication Drug Delivery Insight, which is edited by Sophie Braacken, please read on…

Prosonix has presented new research showing that a combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP) significantly improved co-localisation of the active drug components in the lung. The presentation was made by Prosonix’ Dipesh Parikh at the Drug Delivery to the Lungs 2011 (DDL2011) conference in Edinburgh, UK.

In the presentation, Prosonix describes how its Umax technology has enabled the development of one such example of MCP, which combines budesonide (BDS) and formoterol fumarate dihydrate (FFD) in a single particle, in a pre-determined ratio with “exquisite” control and consistency. The combination of BDS and FFD forms the basis of AstraZeneca’s multi-billion dollar respiratory drug product Symbicort. Combining multiple active drug components into a single particle using Umax® technology is shown, using Raman chemical imaging, to result in optimal co-association and co-localisation of the drug molecules at the correct sites in the lung and respiratory tract.

The concurrent delivery of inhaled corticosteroids (ICS) and long-acting B2-adrenergic bronchodilators (LABA) is a key treatment for asthma and chronic obstructive pulmonary disease (COPD) with mutual synergy of action cited as important for clinical performance. Previous analysis by Prosonix of currently marketed suspension-based MDI and DPI combination product formulations, which consist of individual drug components in a simple mixture, has shown limited co-localisation. Compared with these combination products, the improved co-localisation of MCPs to targeted parts of the lung is expected to achieve more pronounced synergy and additive efficacy on the key target cells directly from the solid state, improving outcomes and leading in turn to lower doses and improved safety and compliance.

To receive regualr articles on drug delivery, please click on the link to Drug Delivery Insight

Mouse here for
Related Links

Espicom Business Intelligence

St Jude Medical Get FDA Approval to Market Unify Quadra

The Medical Technology Blog

FDA marketing green light for SJM’s quadripolar pacing system

The FDA has given St Jude Medical the go-ahead to market its Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead. The company will begin shipping the products to its salesforce to begin providing to customers immediately.

Collectively, the Unify system offers physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. It integrates multiple pacing configurations and Tailored Therapy features that enable physicians to use the system at implant and follow-up, as well as better manage common pacing complications without having to surgically reposition the lead. The system is also approved for remote patient management using the patient care network.

The Quartet lead, used as part of the Unify Quadra system, features four electrodes spaced over 4.7 cm, enabling up to ten pacing configurations. A number of pacing configurations allow the physician to implant the lead in the most stable position without making trade-offs in electrical performance. This includes pacing closer to the base of the left ventricle, which recent studies associate with better patient outcomes and which may be more difficult with traditional bipolar leads. The quadripolar pacing electrodes also provide physicians more options to monitor CRT performance, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.

Heart Hospital of Austin, Texas

The first US implant of the device has taken place at  the Heart Hospital of Austin in Texas. Dr David R. Tschopp , director of electrophysiology at Heart Hospital of Austin , implanted the Unify Quadra quadripolar pacing system to regulate and resynchronise the heartbeat of a heart failure patient. The patient was diagnosed with non-ischaemic dilated cardiomyopathy, a condition resulting in decreased blood supply due to the heart’s main pumping chamber being enlarged, dilated and weak. Unify Quadra was determined to be the best fit because of the patient’s condition and the device’s ability to optimise the delivery of therapy.

Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart, which may reduce the device’s battery life requiring patients to have more surgeries to replace devices or cause pacing to be ineffective. Phrenic nerve and diaphragmatic stimulation also occur when the electrical output from a device inadvertently activates the diaphragm muscle, causing patients to hiccup with the delivery of the pacing stimuli. Both conditions are often due to the location of the pacing lead electrode and, with limited pacing options, may require that the lead be repositioned surgically or CRT be disabled.

Articles source, Cardiovascular Device Business

Espicom Business Intelligence

European Commission Investigates Synthes Takeover

The Medical Technology Blog

European regulatory authority casts an eye over Johnson & Johnson’s Synthes takeover

The European Commission (EC) has opened an in-depth investigation into the planned acquisition of Synthes by fellow orthopaedic company, Johnson & Johnson. The EC now has until 19th March 2012 to take a final decision on whether the transaction would reduce effective competition in the EEA.

The investigation has been prompted by concerns in Europe that the proposed acquisition would remove a competitor from some markets that are already concentrated. An initial investigation showed that the proposed transaction would combine two of the leading suppliers of spine devices and would strengthen the position of Synthes as the current market leader in trauma and CMF devices and of J&J in shoulder devices in a substantial number of EEA member states. The EC also has concerns that the remaining competitors in many of the markets may not be able to exert sufficiently strong competitiveness with the merged entity. The removal of Synthes may also have a negative impact on the level of innovation, leading to a reduction of choice for patients and potentially an increase in prices for the orthopaedic medical devices concerned. Consequently, at this stage, the acquisition raises “serious doubts” as to its impact on competition.

Synthes accepted a US$21.3 billion takeover offer from J&J in April 2011. The deal, which has a target completion date of mid-2012, would make J&J’s DePuy arm the largest orthopaedic device manufacturer in the world.

Espicom Business Intelligence

Diagnostics Focus – Ambulatory Blood Pressure

The Medical Technology Blog

Ambulatory blood pressure may “best predict brain disease and cognitive decline”

Ambulatory blood pressure – not the doctor’s office blood pressure – can best predict the progression of small vessel brain disease and the decline of cognitive function in older people, according to a new study in Circulation: Journal of the American Heart Association. Ambulatory blood pressure is measured by monitoring blood pressure at regular intervals using a special recording device under normal living and working conditions. Clinical or in-office blood pressure is taken in a healthcare provider’s office. The National Institutes of Health funded the study.

According to Dr William B White, senior author of the study and professor of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut School of Medicine in Farmington, the study showed for the first time in an older population that blood pressure measured over a 24-hour period was associated with the progression of vascular brain disease, whereas the typical office blood pressure was not. To determine the effect blood pressure had on the progression of brain disease, researchers examined the change in blood pressure and volume of white matter hyperintensities (WMH) in the brain at baseline and after two years.

WMH are a sign of small vessel brain damage that can be detected using an MRI. In addition to looking for WMH, researchers measured cognitive ability and physical mobility over the two-year time period. Previous studies by the authors and other researchers have shown that increased WMH is associated with cognitive decline. A worsening in ambulatory blood pressure was associated with an increase in WMH and a decrease in cognitive and mobility functions. If medical professionals target average ambulatory blood pressure, it could reduce the progression of small vessel brain disease, researchers stated.

The two-year study included 72 patients – average age 82. For the group, there were no major changes in body weight, clinical or ambulatory blood pressure during the study, and only three patients had severe medical problems, including the development of stroke, heart failure or valvular disease. Researchers found no relationship between clinical blood pressure and WMH; the average volume of WMH, when adjusted for age and “bad” LDL cholesterol, increased significantly over two years from 13.9mL to 20.5mL; and three of the four mobility measures and all of the cognitive measures were significantly related to WMH volume at two years.

The results of this cohort study mean that for older people who aim to stay as functional as possible during advancing age, their blood pressure averaged out of the office, rather than in the office, might be the most important to target and treat.

To start your subscription for more articles like this, please click on the link to Diagnostics Focus, Espicom’s excellent business publication, edited by Sophie Bracken.

Espicom Business Intelligence
 Page 2 of 11 « 1  2  3  4  5 » ...  Last » 

Web Hosting by HostGator