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 Merlin.net 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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Medical Futures & Cipher Pharmaceuticals in Tramadol Deal

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Medical Futures to gain a slice of Canadian tramadol market through deal with Cipher

Medical Futures, a Canada-based pharma company, has signed a pact for Cipher Pharmaceuticals to distribute Durela in Canada. Patent-protected Durela is a once-a-day formulation of tramadol for the treatment of moderate- to moderately-severe chronic pain in adults. It was approved by Health Canada in August and has immediate- and extended-release properties.

As for the particulars of the distribution deal, Cipher will receive an upfront payment from Medical Futures of C$300,000, and could also be eligible for future payments, dependant on net sales milestones. Also, Cipher will get its hands on a double-digit royalty on new sales. Cipher has further responsibily for product supply and manufacturing, which will be taken care of by its supplier, Galephar Pharmaceutical Research.

Medical Futures’ CEO, Colin Campbell, says he is excited to offer Durela in Canada, believing that the product “strengthens and demonstrates [Cipher’s] commitment to providing top tier solutions to the Canadian market”. It appears Cipher is equally delighted with the deal, as it provides valuable royalty revenue to the company. Cipher also recently shook hands on a US$5.5 million US distribution deal for Durela with Vertical Pharmaceuticals, with the former set to receive a payment of US$1 million on the first commercial sale of the product.

With sales of over US$60 million in 2010, the seemingly robust Canadian tramadol market looks like a sure thing for both parties. Medical Futures plans to launch Durela in the first quarter of 2012.

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



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HQ relocation brings Nuvilex closer to the action

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Nuvilex, a company that dedicates itself to the development of natural and biotechnology products, has made the canny decision to up sticks and move its corporate headquarters from Scottsdale, AZ, to Silver Spring, MD – only four miles from the FDA’s doorstep. Nuvilex is hoping that the move – which is in its final stages – will give the company immediate access to the FDA’s resources as the company pursues clinical development of its pancreatic cancer treatment technology, as well as other biotechnology developments in the future.

Not only is the company’s HQ in the FDA’s backyard, it is also only about ten miles away from the National Institutes of Health, and the National Cancer Institute – both major sources of funding grants and research collaborations. To explain the move, Nuvilex’ President and CEO, Dr Robert F Ryan, said the new location “..will facilitate our interactions with the FDA, an important part of our overall strategic planning, especially given our recent entry into biotechnology and our plans for expansion in this area”.

Nuvilex’ pancreatic cancer treatment is currently being geared-up for more clinical trials, and apparently, significant advances are in progress with the company’s live-cell encapsulation technology. Natural products in development include Gluten-Free Cinnergen and others to enhance a healthy lifestyle. The company is also developing products designed for cosmetic use, flu treatment and the use of heavy-metal-free tattoo inks. Future developments are planned for Citroxin and Oraphyte, Nuvilex’ antimicrobial and antinematodal agents.

This article was kindly provided by Sophie Bracken, editor of Drug Delivery Insight for Espicom.



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Cardium set to save best bits of bankrupt Transdel

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Hi and welcome back to the Medical Technology Blog, hope you all had a great weekend, and we’re going to kick off the week with an article from Drug Delivery Insight.

San Diego, CA-based Cardium Therapeutics is making plans to purchase substantially all the business assets of Transdel Pharmaceuticals, also based in San Diego, which specialises in topical pharma products for the treatment of acute musculoskeletal pain. Cardium aims to get hold of Transdel’s assets, including royalty-bearing licence agreements for some cosmeceutical products marketed by third parties that use Transdel technology.

However, Cardium’s main focus is to get its hands on Transdel’s Phase III product candidate, Ketotransdel (TDLP-110), a topical analgesic designed for the treatment of musculoskeletal pain. Transdel’s drug-delivery technology, which is used in Ketotransdel, helps the penetration of a variety of drugs and other products through the skin barrier, allowing agents to be delivered directly to affected tissues. Ketotransdel contains ketoprofen, an NSAID that alleviates pain associated with both inflammatory musculoskeletal disorders like osteoarthritis and rheumatoid arthritis, and traumatic pain in patients with soft-tissue or back injuries. While there are orally-administered ketoprofen-based products registered for sale in the US, the country so far has no topical ketoprofen-based products on offer.

In Cardium’s view, Ketotransdel is capable of offering a new analgesic option within the NSAID market, which is thought to top US$200 million a year in the US alone. Some already-available products for use in the US include third-party products like the Flector patch (sold by King Pharmaceuticals under license from IBSA), Voltaren gel (sold by Endo Pharmaceuticals under license from Novartis) and Pennsaid (sold by Covidien under license from Nuvo Research). All the latter products are based on diclofenac (epolamine or sodium). However, ketroprofen is already widely used in Europe and is available on prescription in the US.

As for the cosmeceutical business rights, Cardium will have royalty-based licensing arrangements with JH Direct and Jan Marini Skin Research, covering the use of Transdel’s delivery technology for cosmeceutical products. The proposed purchase will looks set to broaden Cardium’s technology and late-stage product platform, as well as widening the scope of commercialisation and partnering opportunities now that Cardium’s InnerCool business has been successfully sold to Philips Healthcare.

Cardium is paying US$4.0 million upfront in the form of Cardium shares, of which US$1.0 million would be a contingent value payment to be held in escrow and only be released upon successful registration of Ketotransdel by the FDA within five years of the takeover. Should Transdel accept an alternative offer and terminated the asset purchase with Cardium, Transdel will pay a US$500,000 “break-up fee”, plus certain expenses and costs, to Cardium.

If this deal is approved by the US Bankruptcy Court and goes ahead, the Transdel assets will form part of a new subsidiary of Cardium that would be responsible for co-ordinating the clinical development, commercialisation, partnering and financing for Ketotransdel and related drug-delivery technologies. At the same time, Transdel’s cosmeceutical business would be transferred to Cardium’s MedPodium business, which would be responsible for broadening and expanding these activities and further developing the MedPodium platform, a ‘nutraceutical’ product portfolio and Cardium’s planned Nutra-Apps product line initiative.

 



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Scientists use tumour’s ‘fingerprint’ to test for rare cancer

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Today’s article in the Medical Technology Blog is provided by Sophie Sanderson editor of Diagnostics Focus, please read on…

A team of researchers from the UK look to have come up with a ‘cheap and reliable’ diagnostic test for a rare form of cancer – hereditary leiomyomatosis and renal cell cancer (HLRCC) – which involves screening tumour samples for a particular molecular fingerprint unique to this cancer.

HLRCC is a disorder that causes the development of benign, but often painful tumours in the skin and, in females, in the uterus. Between one in six and one in ten people affected by the disorder will go on to develop an aggressive form of kidney cancer called papillary renal cell cancer. The disorder is caused by mutations, which may be inherited, in a gene responsible for the production of an enzyme known as fumarate hydratase (FH). This leads to an accumulation within cells of fumarate, which promotes the development of cancer cells. Normally, every cell has two copies of each gene: one inherited from the mother and one inherited from the father. HLRCC is said to follow an autosomal dominant inheritance pattern, in which a mutation happens in only one copy of the gene – meaning that a parent with a gene mutation may pass along a copy of their normal gene or a copy of the gene with the mutation.

Led by researchers at the Henry Wellcome Building for Molecular Physiology, University of Oxford, an international team of scientists claim to have identified a particular protein modification that is induced by FH deficiency (and hence an over-abundance of fumarate). This alteration is unique to this type of tumour and can be used as a biomarker – a biological ‘fingerprint’ to identify tumours caused by this mechanism.

For the first time, scientists are now in a position to screen for tumours caused by this rare, but often very serious condition using a test that is simple, cheap and reliable. The test for this protein modification offers great potential as it can be carried out in under two hours and will identify tumours with FH mutations. This approach is also said to be more cost-effective than genetic testing of all possible cases using DNA sequencing. When screening cases of papillary renal cell cancer using this new test, the researchers identified undiagnosed cases of HLRCC for genetic testing.

In the future, by applying this test in all cases of papillary renal cell cancer to identify people with FH mutations, families could receive advice on their own relative risks of developing the disorder and associated kidney cancer. Dr Lesley Walker, Director of cancer information at Cancer Research UK, reinforces the importance of this notion, stating that “…being able to identify other family members who are at risk so they can be monitored more closely is crucial to improving survival rates from this rare aggressive form of kidney cancer.” Tests like this could also help identify other patients with the same mutation, paving the way for the development of targeted treatments for specific groups of patients that could revolutionalise cancer treatment in the future.



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Vivelle-dot, an estrogen patch.

Image via Wikipedia

Welcome back to the Medical Technology Blog once again Mylan are under fire from the authorities (see related articles below) please read on…

Mylan is being sued by Noven Pharmaceuticals and Novartis over alleged infringement of the latter’s Vivelle-Dot (oestradiol transdermal system) patch product. Noven filed the lawsuits in the US District Court for the Southern District of New York and the US District Court for the District of Vermont after Mylan submitted an ANDA application in the US for approval to market a generic version of Vivelle-Dot, before the expiration of the product’s patent protection in 2014.

As Noven and Novartis filed the suit within 45 days of hearing about Mylan’s ANDA submissions, the FDA is not allowed to approve the generic product until June 2013 at the latest, or until a district court decides the patent is invalid or the product infringing. However, Mylan believes it is the first to file an ANDA containing Paragraph IV certification for all strengths, and hopes to qualify for 180 days of marketing exclusivity, if approval is granted.

Mylan’s patch, a twice-weekly oestradiol transdermal system, has been submitted for approval for 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day and 0.1mg/day strengths, for the treatment of the symptoms of menopause, the treatment of hypoestrogenism and the prevention of post-menopausal osteoporosis.

IMS Health says that Vivelle-Dot had sales in the US of around US$215 million for the 12 months ended 31st December 2010. Vivelle-Dot, which was launched in 2002, is marketed by Novogyne Pharmaceuticals, a joint venture specifically set up by Noven and Novartis to promote the product. With the prospect of generic competition taking a slice of its revenues, neither Noven nor Novartis are going to give up that easy and have served notice that they will “vigorously defend” their intellectual property rights from infringement.

Thanks to Sophie Bracken for this article, Sophie edits Espicom’s newsletter Drug Delivery Insight.



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