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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

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Cardiovascular Device Business Product Launch

Everist Genomics is preparing for the market release in January 2012 for its CardioDefender diagnostic system, an FDA-approved and CE marked mobile phone ECG system that provides physicians and patients with hospital-quality heart rhythm monitoring outside of the hospital setting. The system incorporates capabilities that enable physicians to diagnose and treat potentially life threatening arrhythmias that might otherwise be missed.

According to Everist, CardioDefender is the first system to deliver mobile, real-time, beat-by-beat, and quantitative heart monitoring and automated reporting by combining patented analytical mobile phone software with a Bluetooth device and electrodes. The electrodes, which are attached to the patient’s skin, transmit heart rhythm data to the Bluetooth device, which then transmits the data to the mobile phone. The software in the mobile phone analyses the heart rhythm data, and the data is sent to a cardiac monitoring centre which keeps an encrypted record of the data that can be reviewed by physicians. Physicians are also able to receive arrhythmia alerts via their mobile phone, tablet, laptop or desktop computer. In the event of a significant arrhythmia, the  system will automatically transmit an alert to the patient’s physician while the event is occurring.

Following regulatory clearances in 2010,  CardioDefender has already been deployed at more than 150 medical facilities in the US for postapproval commercial evaluation. Between January and October 2011, the number of patient days of heart rhythm monitoring performed with CardioDefender grew from fewer than 5,000 to more than 18,000 patient days per month.

For up to date information on product launches and much more, please click on the link to the Cardiovascular Device Business.

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FDA steps up bid to drive innovation in healthcare

The Medical Technology Blog

The FDA has handed over an award of US$2 million…

…to support two regional ‘Centres of Excellence in Regulatory Science and Innovation’ (CERSI) in the US. The centres, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernise and improve the ways drugs and medical devices are reviewed and evaluated.

In August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”, the main focus of which was to accelerate delivery of new medical treatments to patients, improve paediatric health, protect against emerging infectious diseases and terrorism, enhance safety and health through informatics, protect the food supply, modernise safety testing and meet the challenges of regulation. More recently, in October, the agency announced a related initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. This plan focuses on “continuing dialogue with companies, innovators, patients and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation”.

Working with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioural and manufacturing sciences. The agency chose to pilot the CERSIs in Washington, DC, to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s business publication Drug Delivery Insight.

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Medica 2011

The Medical Technology Blog

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Biologic Therapies bursts onto orthobiologics scene

The Medical Technology Blog

Welcome back to the Medical Technology Blog. We start off the week with an article from the orthopaedics business, please read on…

A new company has been propelled into the orthobiologics industry as the result of a joint venture between device firms Scorpion Medical and Monet Medical. Dubbed Biologic Therapies, the new company will focus on the design, development and manufacture of components for the biologics sector of the medical device industry.

Orthobiology is the inclusion of biology and biochemistry in the development of bone and soft tissue replacement materials for skeletal and tissue healing. Biologic Therapies  will  attempt to take this process to a new level by creating ‘Autologous Orthobiologic Therapy’. The company believes it can use the body’s own stem cells to increase the healing potential and provide quicker restoration of function within muscle, tendon, ligament, bone and cartilage, said Dr R Wade McKenna, owner and operator of Monet Medical and  by an orthopaedic surgeon. Biologic Therapies will be led by President Steve Bales, a former employee of DePuy and Encore Medical.

McKenna’s autologous biologic therapy (bone marrow aspirate stem cells) treatments are designed to augment overall healing and improve surgical and non-surgical results. The treatments are for ligamentous injuries involving the knee, ankle and elbow. Treatments in the knee include ACL, MCL and LCL injuries. In the elbow, stem cells are used successfully to treat acute and chronic medial and lateral epicondylitis. Ligamentous injuries around the ankle are referred to as sprains but can often represent significant tears to the stabilising structures of the ankle. Autologous biologic therapy is used around the ankle in chronic and acute sprains to shorten the recovery time and improve the quality of healing tissue.

As its first product offering, Biologic Therapies is actively working to bring to market a new, patented device for accessing a patient’s own stem cells through the safe and painless harvest of bone marrow. This device is scheduled for market release during the first quarter of 2012. The company believes this device is unlike anything currently available and expects it could become the “gold-standard” for use in stem cell harvesting procedures.

Closely following the stem cell harvesting device will be a range of implant systems for fracture fixation, which will include the ability to introduce stem cells precisely at the fracture site. In addition, Biologic Therapies intends to create a strategic initiative to broaden the training and product support by offering an educational element to surgeons and healthcare professionals. The educational programme will aim to enhance the awareness and efficacy of this emerging technology as well as share Biologic Therapies’ surgical protocols designed to increase the success rate of autologous orthobiologic therapies.

Thanks to Sophie Bracken for providing this article, Sophie edits Espicom’s business publication Orthopaedics Business News.

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Flutiform Presents Good Safety Profile in Asthma Patients

The Medical Technology Blog

Drug Delivery Insight

Good efficacy and safety profile of flutiform in asthma patients seen in ERS-presented studies

Data presented at the European Respiratory Society (ERS) congress shows that a combination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS) and formoterol fumarate (formoterol), a long-acting beta2-agonist (LABA) within a single aerosol inhaler (flutiform, manufactured by Napp Pharmaceuticals) was more effective than each of the compounds administered alone on measures of lung function. It was also found to be effective in treating asthma as fluticasone and formoterol administered concurrently via separate inhalers, and had comparable efficacy in improving the lung function and a similar safety profile with budesonide/formoterol, a licensed combination asthma therapy.

Three Phase III studies for the fluticasone/formoterol combination were presented at ERS…

…the first of which measured the change in FEV1, a common measurement of the lung function, from morning pre-dose at baseline to pre-dose at week 12 seen with low-dose of the fluticasone/formoterol combination compared with formoterol. The change in FEV1 from morning pre-dose at baseline to two hours post-dose at week 12 was also compared with fluticasone in 357 adult and adolescent patients with mild to moderate asthma. This double-blind, parallel group, multicentre study, conducted in patients aged 12 and above, showed superior efficacy of the fluticasone/formoterol combination when analysed against each individual component separately on these endpoints.

The second study was an open-label, parallel group…

…European multicentre study of 210 adolescent and adult patients with mild-to-moderate-severe persistent, reversible asthma. The study demonstrated non-inferiority of the fluticasone/formoterol combination compared with the individual compounds administered concurrently based on post-dose FEV1 at week 12.

A final, double-blind, parallel group trial…

…compared the efficacy and safety of the fluticasone/formoterol combination with the budesonide/formoterol combination in 279 adolescents and adults with moderate-to-severe, persistent reversible asthma. This trial showed that the fluticasone/formoterol combination resulted in comparable improvements with the budesonide/formoterol combination in change in morning pre-dose FEV1 from baseline to week 12. The fluticasone/formoterol combination and the budesonide/formoterol combination were also shown to have similar safety profiles.

The data support previous studies, which have shown the efficacy and safety of the fluticasone/formoterol combination in adults and adolescents (aged 12 years and above). An MAA for the fluticasone/formoterol combination has been submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval and a decision is expected later this year.

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US researchers uncover protein associated with heart attacks

The Medical Technology Blog

Today’s post on the Medical Technology Blog come from Medical Industry Week, Espicom’s current business publication on the medical industry, please read on…

Researchers from Loyola University Chicago Stritch School of Medicine have discovered a possible new blood test to help diagnose heart attacks.

Featured within the Journal of Molecular and Cellular Cardiology, the investigators provided details of a large protein known as cardiac myosin binding protein-C (cMyBP-C), which is released to the blood following a heart attack. Senior author, Dr Sakthivel Sadayappan, believes this could potentially become the basis for a new test, used in conjunction with other blood tests, to help diagnose heart attacks, however, additional studies will be necessary to establish cMyBP-C as a true biomarker for heart attacks.

Between 60 and 70 per cent of all patients who complain of chest pain do not have heart attacks. Many of these patients are admitted to the hospital, at considerable time and expense, until a heart attack is definitively ruled out. An electrocardiogram can diagnose major heart attacks, but not minor ones. There are also blood tests for various proteins associated with heart attacks, but most of these proteins are not specific to the heart. Elevated levels could indicate a problem other than a heart attack, such as a muscle injury. Only one protein now used in blood tests, called cardiac troponin-I, is specific to the heart, however, it takes at least four to six hours for this protein to show up in the blood following a heart attack.

 The Loyola study is the first to find that cMyBP-C is associated with heart attacks. The researchers evaluated blood samples from heart attack patients, and also evaluated rats that had experienced heart attacks. They found that in both humans and rats, cMyBP-C was significantly elevated following heart attacks. cMyBP-C is a large assembly protein that stabilises heart muscle structure and regulates cardiac function. During a heart attack, a coronary artery is blocked, and heart muscle cells begin to die due to lack of blood flow and oxygen. As heart cells die, cMyPB-C breaks into fragments and is released into the blood. Future studies would determine the time course of release, peak concentrations and half life in the circulatory system. Sadayappan holds a provisional patent to determine the risk factors associated with cMyBP-C degradation and release into human body fluid.

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Type II Diabetics Treated with Bydureon Experience Reduced Cardiovascular Risk Factors

The Medical Technology Blog

Drug Delivery Insight – Research & Development

Amylin Pharmaceuticals, Eli Lilly and Alkermes have revealed new analyses from the DURATION-3 and -4 trials showing patients treated with the investigational medication Bydureon (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular (CV) risk factors, in comparison with patients who received commonly prescribed diabetes treatments. The analyses showed that patients receiving Bydureon for the treatment of Type II diabetes experienced improvements in composite endpoints related to body weight, abnormal blood pressure and abnormal lipid levels.

The initial DURATION-3 trial was an open-label study of 467 patients not achieving adequate glucose control using metformin therapy alone or in combination with a sulphonylurea. Subjects were randomised to receive treatment with Bydureon or titrated doses of Lantus (insulin glargine, Sanofi). The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, safety endpoints including hypoglycaemia, CV risk biomarkers and patient-reported outcomes.

Interim results from DURATION-3′s ongoing extension found that patients receiving Bydureon and completing 84 weeks of therapy showed statistically significant reduction in body weight (vs Lantus; treatment difference: 9.8 lbs). There was also, statistically significantly more patients in the Bydureon treatment arm met a composite endpoint of A1C <7 per cent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (15.7 per cent vs 7.9 per cent with Lantus); and met a composite endpoint of A1C<=6.5 per cent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (11.2 per cent vs 5.1 per cent with Lantus).

The 26-week, double-blind, randomised, four-arm parallel DURATION-4 study enrolled 820 drug-naive patients with Type II diabetes and compared Bydureon with metformin, Januvia (sitagliptin, Merck & Co) and Actos (pioglitazone HCI, Takeda) monotherapies. The primary endpoint was reduction in A1C levels, while secondary endpoints included change in body weight along with other parameters of glucose control, CV health and patient-reported outcomes. The post hoc analyses showed patients treated with Bydureon or metformin were more likely to achieve clinically relevant composite goals than patients treated with Actos or Januvia. Researchers evaluated how many patients in each treatment group achieved a composite endpoint of A1C<7 per cent, no weight gain and no minor or major hypoglycaemia (48 per cent for Bydureon vs 22 per cent for Actos, 35 per cent for Januvia and 46 per cent for metformin); and reached a composite endpoint of A1C<7 per cent plus target systolic blood pressure (<130 mmHg) and target LDL cholesterol (<100 mg/dL) (16 per cent for Bydureon vs 10 per cent for Actos, 7 per cent for Januvia and 13 per cent for metformin).

In the DURATION-3 study, gastro-intestinal adverse events were among those most commonly reported; however, the number of new cases of all adverse events declined during the extension phase of the trial. In the DURATION-4 study, the most frequently reported adverse events among Bydureon users were nausea and diarrhoea. These data are consistent with the previously reported profiles of Bydureon and Byetta (exenatide) injection.

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Researchers create human heart cells that can be paced with light

The Medical Technology Blog

This weeks artice on the Medical Technology Blog is taken fromEspicom’s business publication, Cardiovascular Device Business, please read on…

In a paper published in the September issue of the Biophysical Journal, lead author Dr Oscar Abilez, a postdoctoral scholar and PhD candidate in bioengineering, and a multidisciplinary team from Stanford University, describe how they have, for the first time, engineered human heart cells that can be paced with light using a technology called optogenetics. In the near term, the researchers say the advance will provide new insight into heart function. In the long term, however, the development could lead to an era of light-based pacemakers and genetically matched tissue patches that replace muscle damaged by a heart attack.

To create the light-responsive heart cells, the researchers first inserted DNA encoding a light-sensitive protein called channelrhodopsin-2 (ChR2), into human embryonic stem cells. ChR2 controls the flow of electrically charged ions into the cell. For heart cells, the primary ion is sodium, which initiates an electrochemical cascade that causes the cell to contract. They then transformed the optogenetically engineered stem cells into cardiomyocytes those that respond to light.

The key protein for the experiment is ChR2, which is sensitive to a very specific wavelength of blue light and regulates tiny channels in the cell surface. When ChR2 is illuminated by the right wavelength of blue light, the channels open to allow an influx of electrically-charged sodium into the cell, producing a contraction. After creating the cells in a laboratory dish, the researchers tested their new cells in a computer simulation of the human heart, injecting the light-sensitive cells in various locations in the heart and shining a virtual blue light on them to observe how the injections affected contraction as it moved across the heart.

In a real heart, the pacemaking cells are on the top of the heart and the contraction radiates down and around the heart. With these models, the researchers say they can demonstrate not only that pacing cells with light will work, but also where to best inject cells to produce the optimal contraction pattern.

The long-term goal is the development of a new class of pacemakers. At present, surgically-implanted electrical pacemakers and defibrillators are commonplace, regulating the pulses of millions of faulty hearts around the world. However, Abilez adds that neither is without problems – pacemakers fail mechanically and the electrodes can cause tissue damage. Defibrillators, on the other hand, can produce tissue damage due to the large electrical impulses that are sometimes needed to restore the heart’s normal rhythm. In the future, the researchers envision that bioengineers will use induced pluripotent stem cells fashioned from the recipient’s own body, or similar cell types that can give rise to genetically matched replacement heart cells paced with light, circumventing the drawbacks of electrical pacemakers.

Co-author, Dr Christopher Zarins, professor emeritus of surgery and director of the lab, speculates the the work could result in a pacemaker that is not in physical contact with the heart. Instead of surgically implanting a device that has electrodes poking into the heart, engineered light-sensitive cells would be injected into the faulty heart and used to pace the heart remotely with light, possibly even from outside of the heart. The leads for such a light-based pacemaker might be placed outside the heart, but inside the pericardium, the protective sack surrounding the heart. Another concept to be explored is a pacemaker placed inside the heart chambers, as with traditional pacemakers, whose light can travel through the intervening blood to pace light-sensitive heart cells implanted inside. Since the new heart cells are created from the host’s own stem cells, they would be a perfect genetic match.

The authors conclude that optogenetics could also lead to advances beyond the heart. It might lead to new insights for various neuronal, musculoskeletal, pancreatic and cardiac disorders, including depression, schizophrenia, cerebral palsy, paralysis, diabetes, pain syndromes and cardiac arrhythmias.

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US joint replacement registry gets fully under way

The Medical Technology Blog

Hi and welcome back to the Medical Technology Blog, and today’s post come from Espicom’s excellent news publication, Orthopaedic Business News, please read on…

Like the National Joint Registry of England & Wales before it, the American Academy of Orthopaedic Surgeons (AAOS) has been busy with the task of establishing the American Joint Replacement Registry (AJRR) – a project designed to collect data on all primary and revision total joint replacement procedures in the US. The registry’s mission is to improve patient safety and quality of care, as well as reducing the associated cost. With that mission in mind, the AJRR has recently completed its pilot programme of data collection.

Dr John Callahan, Vice President of AAOS and team leader of the AJRR project, said that past medical registries have been shown to help reduce the cost of medicine and, in particular, the burden of joint replacement. Callahan believes that decreasing revision surgeries by half would save millions anually for healthcare payers as well as for the US government. “Because of this, US Congress is interested in including registries in healthcare reform. The AJRR will be able to provide information in a timely manner, where it can be analysed by orthopaedic surgeons”, he said.

Short-term, the registry aims to establish an infrastructure and a uniform system for the collection of information and monitoring outcomes of total joint replacement in the US, as well as identify patients who may need follow-up evaluation, thereby increasing patient safety. Long-term, the registry’s goals are to create a real-time feedback mechanism in order to detect “sub-optimal” performance, and establish a uniform system that can be used to expand understanding of total joint replacement for research to improve patient care.

AAOS statistics show that in 2006 alone, more than one million hip and knee replacement took place in the US. Of these, around 7.5 per cent were revision surgeries, resulting in 77,000 procedures, at a cost of over US$3.2 billion. The AAOS has projected that the AJRR will reduce healthcare costs by around US$1.3 billion over the next 20 years. The AAOS believes that even a 2 per cent decrease in revision rates could potentially save US$65.2 million a year. Similar registries in Sweden, England & Wales, Canada and Australia have seen up to a 10 per cent reduction in revision rates as a direct result of their own registries.

However, the registry is not all about saving cash. Explaining the registries main aims and focus points, Dr David Lewallen, Chair of the AJRR Board of Directors, said there is a national interest in registries, particularly how patients will benefit. In the past, national data collection of hip and knee implants has helped to improve care by allowing surgeons, device manufacturers and hospitals to better understand what aspects of joint replacement is successful, and what needs to be improved. Lewallen said that the AJRR will enable surgeons, hospitals and device manufacturers to review their own data and compare their performance with similar institutions, in order to understand where opportunities for improvement may exist. The registry will also be a resource for patients, who will be able to contact the registry to find out what methods and devices were used at the time of their surgery.

The AJRR aims to gather data on all replacement and revision surgeries, including younger patients who are not recipients of Medicare – with the ultimate goal of achieving 90 per cent participation. The AJRR was set up in June 2009, and enrolment began in 2010. Participating hospitals have been submitting data for only a few months, but already information on over 3,600 primary and revision replacements has been assembled from eight different reporting sites, marking the culmination of the pilot stage.

Following an updated report on the pilot project, covering lessons learned and data analysis, the AJRR Board of Directors have begun formulating strategies for outreach recruitment, expanding resources and efficient data collection methods as the registry moves to full production. The AJRR’s timeline for 90 per cent participation in the registry is for October 2013.

At the moment, the AJRR is focused on collecting so-called “level-one” data, which includes a number of core data elements, such as patient, surgeon, procedure and hospital data. Each patient, surgeon and hospital has a unique identifier, which enables index procedures to be linked to subsequent events, permits patients to access their own information, allows data to be linked to other databases and helps maintain confidentiality.

Level-two data include variables that could enhance the value of the data analysis and allow risk adjustment, such as the patient’s body mass index and any comorbidities, as well as process of care data such as antibiotic prophylaxis. Level-three data will focus on outcomes and patient satisfaction, while level-four data (such as radiographs) provide more in-depth analysis of why and how implants or procedures fail.

Lweallen said the next step of the AJRR is to recruit a Medical Director to supervise operations. The registry is also moving toward implementing systems that will enable a wide range of hospitals and systems to submit data.

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