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

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FDA steps up bid to drive innovation in healthcare

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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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Biologic Therapies bursts onto orthobiologics scene

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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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Non-Surgical Treatment for Varicose Veins

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As the NHS cuts start to bite, could a treatment for varicose veins provide one of the answers?

Maybe not! But Medical Industry Week this week highlighted the rather grand suggestion that a non-surgical treatment for varicose veins could save the UK’s National Health Service over £17 million annually in healthcare costs, and help 7,000 patients avoid further treatment due to unsuccessful alternative treatments. It’s not going to solve all our problems, but if it’s true then it’s a good start!

All medical device companies like to big up their respective device and technologies from time to time, particularly when one considers that regulatory authorities from across the country are tightening the budgets.  So it remains to be seen whether VNUS’ claims are just marketing puff, but it’s interesting to see how companies are increasingly using costing as a sale push, in addition to all the stated benefits of improving healthcare.

Developed by US-based VNUS Medical Technologies, the VNUS Closure Procedure involves a hospital stay of a couple of hours, treatment under local, rather than general anaesthetic, and claims a much faster recovery time with most patients able to walk out of the treatment room unaided. The procedure is also much less resource-intensive than surgery to the NHS, particularly compared to conventional varicose vein stripping, which takes up a great deal of operating theatre time.

For the same costs, the company said this week that a further 25,000 patients could be treated earlier and avoid pain, or discomfort. Further savings are on offer as the procedure can be carried-out in a treatment room so it has the potential to free-up theatre-time, enabling the NHS to treat other serious conditions more quickly and to reduce those all-important waiting-times.

On its own, the VNUS procedure may not represent a significant dent in the £20 billion of spending cuts that the NHS is faced with securing over the next four years, but getting on top of some of these, arguably less glamorous treatments could collectively make a positive impact on meeting this ambitious target. Medical Industry Week argues that it is time to take a closer look at these sort of treatments in a bid to meet a target that even the NHS Confederation says is unlikely to be achieved with the timescale.

This article was provided by Lawrence Miller, editor of Medical Industry Week, and the medical newsletters teamleader.

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US regulatory bodies respond to rapid rise of modern wireless technology and apps for medical devices

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The proliferation of broadband and wireless-enabled medical devices has prompted the FDA and US Federal Communications Commission (FCC) to issue a joint plan aimed at bringing clarity to the issue.

Although these devices represent the opportunity to enhance health and reduce the costs of healthcare, they aren’t without a few risks too. The devices, which include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems, are increasingly playing a major role in treatments.

The US government agencies have come to the conclusion that clear guidelines are needed to make sure these devices are operated in a safe, reliable and secure manner. The FDA, in particular, is of the opinion that the industry, healthcare providers, patients, and other interested stakeholders in the medical environment should have clear regulatory pathways, processes and standards to bring the technology to market.

Although specific details are thin on the ground at the moment, the aim still pretty noble enough. “All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology” – the communiqué boldly claims.  At the end of the day though, by clarifying each agency’s scope of authority with respect to these devices, the hope is that interested parties will get a clearer picture of the regulatory process, streamline the application process, and make sure that innovation doesn’t get stifled through bureaucracy.
The move comes as the FDA grapples with even more complex issue of software applications (apps), the likes of which are increasingly been used in mobile medical technology, such as mobile phones, tablet computers and PDAs.

In general, the FDA’s position is that if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it is run. This can range from mobile apps used on mobile phones to analyse glucose meter readings.

In consultation with the US public, the agency is looking to establish formal guidance that define a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. The offending apps could be used as an accessory to medical device already regulated by the FDA transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.

There’s an obvious need for some kind of monitoring in this area. Nowadays an app can be used by a healthcare professional to make a specific diagnosis by viewing a medical image on a mobile phone or tablet, whilst some apps can turn a smartphone into an ECG machine and be used to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. Understandably, the FDA is of the opinion that these particular mobile apps pose the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended.

The FDA has set a deadline for 19th October 2011 for interest parties – including manufacturers and app developers, to submit comments relating to the agency’s draft policy document, with a view to formulating clear guidance on the matter once and for all.  One thing is for sure, it’s a good idea to revise the present guidelines – the FDA’s last significant attempt to address the topic was made in 1989!

Thanks to Lawrence Miller for yet another great article, Lawrence is the Espicom’s editor for Medical Industry Week, and medical newsletter teamleader. For more articles like this, or to start your subscription please click on the link to Medical Industry Week


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ReGen Biologics has rejected the FDA’s offer of a hearing, before the agency formalises its plans to annul its 510(k) clearance of the company’s Menaflex meniscal implant.

Dr Gerald E Bisbee, Chair and CEO of Regen, thinks that any meeting would be a big waste of time and he might have a point judging by his company’s dealings with the FDA over the past six years. Bisbee says “enough is enough”, because safety and efficacy issues regarding the device were reportedly settled years ago at an FDA Advisory Panel meeting.  Bisbee said members of that panel were in favour of Menaflex, and any issues that need attention are the FDA’s own “arbitrary and unfair processes”.

Menaflex is a reabsorbable mesh that is used in meniscus surgeries to reinforce damaged or weakened meniscal soft tissues, providing a scaffold for replacement by the patient’s own soft tissue. The device was cleared in Europe in 2000 and 2006 for use in medical meniscus injuries and lateral meniscus injuries, respectively. After a three-year review under the 510(k) process (which included input from  the Advisory Panel of independent experts), December 2008 saw the FDA rule that the device is safe and effective, and cleared it for use. But after a change of management at the FDA two years later, the agency re-reviewed its own approval of the product. Dr Jeffrey Shuren, Director for the CDRH, rationalised the re-review by citing a September 2009 FDA report, of which he was co-author, called “Review of the ReGen Menaflex: Departures from Process, Procedures and Practices Leave the Basis for a Review Decision in Question”.

The report said that the original FDA review of the device was subject to a number of internal FDA departures from processes, procedures and practice that were compounded by external pressures. Bisbee believes that a careful reading of the report shows that within the reviewing there was “…widespread internal disagreement and confusion about the legal standard for 510(k) review”, and that the OCC (the FDA’s legal division), “advised that a review of a 510(k) involves a comparison of a device to a predicate rather than to a standard-of-care that there was no legal foundation for requiring a company to demonstrate clinical benefit in a 510(k)”. Bisbee says this interpretation supports ReGen’s argument that the CDRH was holding the device to the wrong review standard.

Almost exactly a year ago, ReGen wrote to the FDA Commissioner Hamburg about the report. The letter provided 0a detailed analysis of the report, suggesting that it contained “…inaccuracies, misrepresentations, speculation and bias, and omits material information… The extent and depth of these irregularities raise the question of whether the preliminary report was intended to discuss the results of the agency’s internal investigation or instead provide support for a foregone conclusion, ie, a re-examination of the Menaflex device 510(k) clearance”.  According to ReGen, Commissioner Hamburg is yet to respond to the letter.

The FDA’s re-review of Menaflex took almost a year and included a second Advisory Panel meeting, concluding with the decision that the device had a different intended use. According to this decision, Menaflex, despite being similar to other approved meshes, would not be regulated as a surgical mesh pursuant to 510(k), but would be treated as a novel Class III device. Shuren stated his intention to revoke the FDA’s original 510(k) clearance, a move that Bisbee finds “unbelievable”.

As it has declined the FDA’s offer of a hearing, ReGen has put the agency on notice that it will seek an “unbiased” review of Menaflex’ approval status under US law. ReGen says it knows the FDA has no legal authority to revoke Menaflex’ clearance, and believes the agency botched its review of the product at every stage. In a nut shell, will the FDA’s opinion that devices can be re-reviewed and revoked at any time, even long after they have been approved, chill US investors’ eagerness to invest in the development and distribution of new devices?

Thanks to Sophie Bracken for this article, Sophie is editor of Orthopaedic Business News Espicom’s monthly digest of news from the industry.

Thanks for reading, Paul.

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Medical Technology Development Costs Cause Concern In US

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Biosensors highlights concerns over the time and costs of approving devices in the US

Jeffrey Jump, the recently appointed CEO of Biosensors is a frustrated man. His company – a Singapore-based stent manufacturer – has grown increasingly exasperated with the regulatory climate that exists in the US and he wants everybody to know just how difficult it is getting a device approved by the FDA.

Concerns over the lengthy and demanding regulatory process in the US are not new. For years, many of the groundbreaking devices to emerge in the healthcare market – not just in cardiovascular devices – have made their debut in markets outside of the US first. Indeed, many US companies have found themselves marketing their technology in Europe long before the clearance process in the US has been negotiated. Europe’s gain has been the US’s loss but there are fears the gap is widening. In its defence, the FDA’s supporters will argue that its processes are there to protect the American people and if that means a more strenuous approval process then so be it. However, as Mr Jump suggests, it seems as if this regulatory gap is getting worse and the issue has to be addressed.

Worldwide, the approval process continues to take less time and, more importantly, costs less to fund. It takes a device manufacturer three to five years to get a medical device approved in Japan and China, at cost of US$3 million or less in each market. In Europe, the time can range from six months to two years and cost just US$2 million. In contrast, getting approval in the US for a medical device can take between two and seven years and cost between US$50 to US$100 million.

This discrepancy in time and costs is raising a few questions that Mr Jump and other CEOs increasingly feel need to be answered as a business. Most importantly, is it really worth spending that much time, effort and money on securing FDA clearance? It’s an issue that doesn’t just trouble the smaller companies, even the bigger ones are weighing up the options. According to Mr Jump, major medical device companies could be facing bills in the region of US$200 million just to get approval for their next-generation stent technology in the US and, as a direct result, may seriously consider abandoning the US market for this important technology.

With the global economic downturn very much in the memory of CEOs, the stringent and lengthy requirements needed to accommodate the FDA have also seen innovative companies bite the dust as they get bogged down in the regulatory steps imposed by the FDA. For Biosensors this brings opportunities to acquire technology at much lower prices because these companies simply run out of cash and time.

Already, Mr Jump has snapped up CardioMind, a US company which has developed a drug-eluting stent (DES) for the treatment of small vessel lesions, and plans to complete the acquisition of another undisclosed device company shortly. Paying for such high quality assets at knockdown prices is possible for Biosensors because it looks to gain its market share from markets outside of the US, which ultimately place considerably less strain on its cashflow. How long will it be before other companies choose a similar path?

Whilst Abbott will probably find the prospect of not marketing its bioreabsorbable vascular scaffold (BVS) platform in its home country ultimately unpalatable, and you could say it’s big enough to handle the costs, the debate is unlikely to go away. China is set to become the largest market for medical device by 2016, so why go through the trials and tribulations of the US when there are richer pickings to be had elsewhere? Biosensors has already closed its R&D operations in the US and transferred its activities back to Singapore and its R&D centre in Morges, Switzerland – also a centre for R&D for Medtronic and Edwards Lifesciences – because the costs of manufacturing and marketing medical devices in the US do not justify the potential returns.

The FDA is unlikely to be too concerned at the comments made by Biosensors, even if they are shared by the CEOs of some of the largest US medical device companies.  But that could change in the future as there is a real possibility that advanced technology – and US-developed technology in particular – could find itself not available in the US, or at least be available several years behind the global market. This has potential ramifications not only for the US healthcare system but also for the skills base in the US. Will the US be able to keep hold of its expertise if companies are increasingly outsourcing such facilities internationally?

For Biosensors, the die has been cast. The company is committed to marketing its BioMatrix Flex abluminal biodegradable polymer DES in markets outside of the US, and it doesn’t market or manufacture any interventional cardiology products in the US. That’s not say the Biosensors is totally excluded from the US market – it also sells bare metal stents and balloon dilation catheters, as well as a sizeable business that includes critical care catheter systems, haemodynamic monitoring and related devices used during heart surgery procedures and intensive care treatment. It is also handily placed should Abbott market its BVS device in the US as it also incorporates royalty earning Biosensors technology. But, despite all of these points, you can’t help share Mr Jump’s disappointment that the US market is rapidly becoming out of bounds to innovation.

This post was brought to you by Lawrence Miller, Espicom Business Intelligence’s medical news team leader.

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