November 15, 2012
Medical device executives will descend on Capitol Hill today to press members of Congress to address the 2.3% medical device tax before it takes effect in January.
Medtech leaders from across the U.S. joined an executive fly-in organized by a trio of industry lobbying groups – the Medical Device Manufacturers Assn., the Medical Imaging & Technology Alliance, and the Advanced Medical Technology Assn.
“Without action from Congress, implementation of the medical device tax will cost our economy thousands of high paying jobs,” MITA executive director Gail Rodriguez said in prepared remarks. “These job losses will directly impact patient access to the most advanced, life-saving medical technologies available.”
The fly-in includes executives more than 50 executives from members of the medtech lobbying groups, who will will present lawmakers with a call to action with more than 800 signatures, representing “hundreds of thousands of medical technology jobs,” according to a press release.
The letter includes support from physician groups, venture capital firms and other organizations asking the Senate to repeal the 2.3% levy on medical device sales, which device makers will start paying in at the start of next year.
“This damaging tax will force job cuts and investments in tomorrow’s treatments and cures,” AdvaMed president & CEO Stephen Ubl said in prepared remarks. “Continued medical innovation is key to driving public health gains by reducing costs associated with chronic diseases like diabetes and obesity and catalyzing economic growth through healthier more productive people and by creating high quality manufacturing jobs. Simply put healthier lives mean healthy economies.”
The medical device industry is expecting to pay about $2.5 billion to comply with the medical device tax, representing a nearly 30% increase in the industry’s current federal tax burden.
Should the 2.3% medical device excise tax survive the coming onslaught of repeal lobbying, the industry will have to come up with about $2.5 billion to comply with the levy in 2013, according to new estimates.
Medtech industry lobby AdvaMed released the results of their latest analysis of the impact of the excise tax, which suggests that next year’s total federal tab may be nearly 30% larger than the industry currently pays.
The analysis, commissioned by AdvaMed and prepared by Ernst & Young, estimated the 2013 medical device tax burden, including both the federal income tax and the new excise tax on medical device sales.
The analysts estimated that next year’s federal income tax will amount to about $8.7 billion and that the excise tax would mean another $2.5 billion, representing a 29% increase in the federal tax burden.
The medical device excise tax, which takes effect Jan. 1, 2013, is a 2.3% levy on all U.S. sales of applicable medical devices. The measure was contained in President Barack Obama’s landmark Affordable Care Act, and was designed, alongside other taxes, to help support the healthcare reform law.
The tax was slated to raise about $20 billion over 10 years to help fund the ACA, but more recent estimates, including MassDevice.com’s, put the total tab closer to $30 billion.
Some companies have begun estimated their individual tax obligations for 2013, including breast imaging devices maker Hologic (NSDQ:HOLX) which this week published its Q4 and full-year 2012 earnings, guiding low for the next year based partially on a $25 million hit from the tax.
Becton Dickinson & Co. (NYSE:BDX) announced earlier this month that it expects next year’s excise tax to cut about 3% from its bottom line.
The tax is applied to all U.S. sales regardless of the profitability of the affected company, leaving some smaller device makers with a huge dent in their bottom lines or, in some cases, a swing back to the red.
The tax is just week away from taking effect, but AdvaMed remains “cautiously optimistic” that they can get a repeal effort addressed during the so-called “lame duck” period between election day and the seating of a new Congress.
A winning strategy for the medtech industry may hinge on re-framing the repeal effort as one addressing tax reform rather than healthcare reform. In February the medtech lobbying group released a set of principles for modifying the U.S. tax system, hoping to attract Democratic support for striking the tax.
“What we’ve seen is an evolution of the issue from being looked at as a healthcare reform law issue to being looked at as a tax-and-jobs issue,”AdvaMed government affairs head Juan Carlos Scott told MassDevice.com last week. “The result of that evolution is we’ve seen growing bipartisan support for addressing the tax.”
The next step, then, is to figure out how to get repeal back on lawmakers’ roster. There aren’t any measures yet scheduled to address the tax, but industry stakeholders are ready to spring into action as soon as an opportunity appears.
“We need to see what vehicles materialize before we know whether that opportunity exists, but we’re making ourselves ready to try and capitalize on the opportunity,” Scott told us.
The groups are hoping to gain favor via face-to-face interaction. Both AdvaMed and MDMA are preparing an executive “fly-in,” sending medical device leaders to Capitol Hill this week to press legislators on the medical device tax.
November 14, 2012 by Arezu Sarvestani
A look at the internet chatter surrounding the medical device industry with some of most searched-for companies of the last month.
2. Johnson & Johnson
4. St. Jude
Boston Scientific’s 3rd-generation Synergy drug-eluting stent lands CE Mark approval in the European Union.
Boston Scientific (NYSE:BSX) said it won CE Mark approval for its Synergy drug-eluting stent, with a bioabsorbable coating designed to deliver the drug everolimus over the 3 months it takes to dissolve.
The company said Synergy is slated for limited release in the European Union and elsewhere by early 2013, with a broader commercial launch on deck for early 2014. The stent is built on Boston Scientific’s platinum-chromium chassis, which the Natick, Mass.-based medical device company touts as more visible under X-ray and able to be built with thinner, more flexible struts.
The CE Mark application was based on BSX’s Evolve trial comparing the Synergy device with its Promus Element DES. The Synergy’s coating is applied only to the exterior of the stent, whereas the Promus Element’s coating is applied to the interior and exterior.
Limiting exposure to the polymer, the result of a 7-year R&D program, according to a press release, helps reduce the risk of late adverse events associated with prolonged exposure.
Kevin Ballinger, president of BSX’s interventional cardiology division, called the Synergy “a premium workhorse drug-eluting stent that eliminates long-term polymer exposure, promotes optimal healing and provides confident deliverability” in prepared remarks.
The 291-patient Evolve study compared 2 versions of the Synergy device with the Promus Element. One of the Synergy arms received stents coated with a half-dose of everolimus, the other with a full dose. Results from the study, published in the April issue of the Journal of the American College of Cardiology, showed that the Synergy stent met its primary safety endpoints (target lesion failure at 30 days) and its efficacy endpoints (in-stent late loss at 6 months). Boston Scientific said the Synergy device posted a target lesion revascularization rate of 1.1% and a 0% rate of stent thrombosis after a year.
The company is planning a 2nd, 1,684-patient trial, Evolve II, to support applications for approval in the U.S. and Japan, according to the release, and “anticipates additional studies to assess outcomes, including the potential for reduced dual antiplatelet therapy.”
I had a great boss at the first medical device company I ever worked for. He had been a senior executive at US Surgical since nearly the beginning, and as part of his experience he received a lot of training. I had recently finished one year of training on lean manufacturing and I was ready to turn his plant upside down with a flurry of Kaizen events. His comment was, “Every single training program is the same.” You can boil it down to just one phrase:
If you haven’t been paying attention, the European Commission has released the proposed regulations for IVD and medical device products in Europe. These two documents are massive changes to the existing Directives. Since the regulations are proposals, rather than approved regulations, most people seem to be taking the approach of “wait and see”.
Big Mistake! Especially if you work in the IVD sector.
There is a 21-page introduction—including the cover page. There are 90 articles, and 14 annexes. The total number of pages is 143. Most people are skimming it once and then digesting it in pieces because the current directive is only 43 pages. Some of the changes are huge!
For example, instead of having Notified Body involvement for 10-20% of the IVDs on the market, now we will have 80-90% of the IVDs requiring Notified Body approval. Distributors and Importers will we required to register—and early (possibly 2013). Finally, we will now be required to have Qualified Regulatory Personnel to review the product for conformity and release it.
These are major departures from the current directive and it will take a few years to be compliant. Companies need to start now! How else are you going to renegotiate all your distributor contracts in Europe? Also, you will need to train and recruit regulatory experts. If they don’t already have 2 years of experience in IVD manufacturing—they won’t be qualified. Consultants like me will be creating training programs for manufacturers and their partners. The Notified Bodies will be certifying distributors and importers.
To prepare for these changes, you need to start planning now. Next Tuesday, October 30 I will be presenting a webinar specifically on regulatory updates for Companion Diagnostics in the EU, USA and Canada. In preparation for this, I recommend that you finish reading the new regulations (the link is in my helpful links page, which is buried one-level down under the resources tab. Next I recommend that you download my new and improved FREE correlation table (http://www.medpoint.com/medpoint-webinar-companion-diagnostics-regulatory-updates-for-fda-eu-canada/). It helps you link the current directive with the new proposal. It started with copying Annex IV, but then I added some help and put all the information in an Excel spreadsheet to supplement sorting and resorting of data as needed. The link for this free download is: http://13485cert.com/new-free-download-2/.
Please register for MedPoint’s webinar on Companion Diagnostics (http://www.medpoint.com/medpoint-webinar-companion-diagnostics-regulatory-updates-for-fda-eu-canada/). I will review pieces of the new EU proposal, but it will also cover trends in the USA and Canadian markets.
Companion Diagnostics Webinar: Regulatory Updates for the FDA, EU and Canada
For information & sign-up go to here: http://alturl.com/s8nxp
Instructor: Robert Packard
Title: Regulatory Consultant
Duration: 60 minutes (including 10-15 min. Q&A)
Event Type: Live Event
Event Date: Tuesday, October 30, 2012
Event Time: Noon to 1:00pm Eastern Time
Companion diagnostics are one of the key components of personalized medicines. Companion diagnostics are used to identify the presence or absence of biomarkers that will be used to select appropriate patient populations for drug products. Only a handful of drug products have associated companion diagnostic products that are approved for use with the drug products, but the market is growing quickly.
Health Canada and the US recently had several new companion diagnostic products that were approved, but the FDA is planning to release a final version of the guidance document for this product category this year. In parallel with these changes, the EU has published draft regulations for IVD products that will impact future approval of these novel products.
This intermediate-level webinar presentation will compare the proposed changes to the IVD regulations for the EU, the US FDA’s Draft Guidance Document for Companion Diagnostics, and the Canadian regulations regarding Companion Diagnostics. Best practices for design of clinical studies and navigating the regulatory submission process will also be reviewed.
Go here to register: http://alturl.com/s8nxp
Who will benefit most:
This topic applies to personnel / companies in the pharmaceutical and in vitro diagnostic (IVD) device industry. The employees who will benefit most include:
· Senior management,
· Regulatory affairs,
· Quality Assurance,
· Engineering / R&D, and
· New product development teams.
*Please note: Once purchasing a ticket, you will be e-mailed the link to gain access to the webinar. Each registration covers one line connected to the webinar. Attendees dialing from separate locations are required to have separate registrations.
Questions about our events?
· How and when will I receive the dial-in information?
· The Presentation link isn’t working, how do I retrieve that?
· How do I receive my Certificate of Attendance?
· Can I receive a discount for buying more than one (1) conference?
About the Speaker
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. Robert has worked with companies from start-ups to Fortune 100, in the USA, Canada, Mexico and Japan. His specialty is helping companies with regulatory submissions for high-risk medical devices and drug/device combination products. His regulatory expertise includes: CE Marking, Canadian Medical Device Applications, 510(k) Submissions, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing and Sterilization Validation. He has held previous positions in R&D, Manufacturing Operations, Quality Assurance and Regulatory Affairs—up to the level of CEO/President. In addition, Robert has extensive technical experience in Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategic Planning. He was a 3rd party auditor for one of the largest Notified Bodies, and he conducts training workshops internationally on a variety of regulatory subjects. Robert is a graduate of UConn in Chemical Engineering.
The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.
An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening and cause significant disability in survivors. The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm. Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women.
The size of an aneurysm can vary from small (less than .25 inches) to giant (larger than 1.25 inches). Its shape may also vary; for example, it may be balloon-like with a narrow neck extending from the artery or it may resemble a bulge with a wide or indistinct neck.
The Pipeline Embolization Device (PED) is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy that can be used to block off large, giant, or wide-necked aneurysms in the internal carotid artery, a major blood vessel supplying blood to the front of the brain. The device can also reduce the likelihood that an aneurysm will rupture.
To implant the device, the Pipeline is attached to the end of a catheter, which is inserted into an artery in the leg. The catheter is threaded into the carotid artery and into position at the aneurysm where the Pipeline is expanded against the walls of the artery and across the neck of the aneurysm, cutting off blood flow to the aneurysm. The blood remaining in the blocked-off aneurysm forms a clot which reduces the likelihood the aneurysm will grow bigger or rupture. Aneurysms successfully treated with the Pipeline will often shrink over time.
“The Pipeline Embolization Device offers neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic when treating carotid artery brain aneurysms,” said Christy Foreman, acting director, Office of Device Evaluation, Center for Devices and Radiological Health.
As part of the approval process, the FDA reviewed results from a study that followed 108 patients between ages 21 and 75 who had a large or giant aneurysm with no discernable neck in certain sections of the internal carotid artery. Results showed that one year after implantation 70 percent of aneurysms remained blocked off without significant narrowing (stenosis) of the section of the artery treated with the Pipeline device.
The same study tracked adverse events associated with the Pipeline and showed that ten strokes occurred in 9 patients in the year after treatment, significantly less than the 20 percent rate expected for this condition. Patients also experienced minor adverse events such as headache, bleeding, nausea and vision problems.
The Pipeline should not be used in patients with an active infection or patients who cannot take antiplatelet therapy (medication that interferes with blood clotting), such as aspirin. Patients should receive adequate antiplatelet therapy prior to surgery to place the Pipeline. The Pipeline device should not be used to treat an aneurysm with a stent previously placed across its neck.
The Pipeline Embolization Device is manufactured by ev3 of Menlo Park, Calif.
U.S. Food and Drug Administration
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) approval of two new irrigated ablation catheters – the Safire BLU(TM) Bi-directional Irrigated Ablation Catheter and the Therapy(TM) Cool Path(TM) bi-directional ablation catheter. These two new catheters have several key design features that offer physicians additional control, including bi-directional deflection, a new shaft with higher torque response, a lower fluid infusion rate when compared to other commercially available irrigated ablation systems, and a choice of handles.
St. Jude Medical ablation catheters are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart’s ability to effectively pump blood throughout the body. Ablation catheters are thin flexible tubes that deliver radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars, that interrupt the abnormal electrical signals that contribute to irregular heart rhythms. Because the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature, the Safire BLU and Therapy Cool Path ablation catheters were designed with an irrigated catheter tip. Irrigation can help to reduce some of the risk factors associated with the heat of the RF energy.
The Safire BLU and Therapy Cool Path irrigated ablation catheters feature a bi-directional deflection capability that provides enhanced maneuverability, which allows physicians to reach challenging anatomic locations. The bi-directional steering turns up to 180 degrees in both directions to allow physicians to better position the tip of the catheter during ablation procedures. This flexibility promotes efficiency and was designed to provide electrophysiologists with increased control over their delivery of ablation therapy.
The bi-directional steering in these catheters is complemented by a shaft that is designed to more efficiently transmit torque (or turning force) from the steering handle to the catheter tip. This improved capability enables the physician to position the catheter with greater precision.
“The new bi-directional irrigated ablation catheters from St. Jude Medical offer innovative features that provide additional control when treating cardiac arrhythmias. The torque response, catheter tip stability and ability to make very fine movements result in excellent catheter performance in complex ablations,” said Dr. Larry A. Chinitz, Director of Cardiac Electrophysiology and Invasive Cardiology at New York University School of Medicine.
The handles of the Safire BLU and Cool Path catheters were designed to be ergonomically appealing and provide physician comfort for both routine and complex ablation procedures. Physicians have the flexibility to choose the handle style that they prefer – the ComfortGrip(TM) for the Safire BLU catheter or push/pull style handle for the Therapy Cool Path catheter.
“The improved handling and catheter control of our new bi-directional catheters can assist physicians in accessing difficult-to-reach anatomic locations. This will allow for more predictable, repeatable and effective lesion formation so physicians can focus their attention on the patient,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “St. Jude Medical is pleased to offer these two new catheters and provide physicians the unique benefits of bi-directional steering, along with the choice of handle that best suits their preference.”
St. Jude Medical
Boston Scientific Receives FDA Approval Of New Clik™ Anchor For Precision Plus™ Spinal Cord Stimulator SystemMarch 28th, 2011 by jessica
Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Clik™ Anchor for its Precision Plus™ Spinal Cord Stimulator (SCS) System, the world’s first rechargeable SCS device for chronic pain management. The Clik Anchor features an innovative locking system designed to improve lead anchoring speed and consistency. Locking into place on the lead with a simple turn of a hex wrench, it provides tactile and audible confirmation for physicians that the lead is secured. The Company is introducing the Clik Anchor at the American Academy of Pain Medicine Annual Meeting, which begins today in Washington, D.C.
“The Clik Anchor is easy to use and gives me confidence that the lead is secure,” said Salim Hayek, M.D., Ph.D., of the University Hospitals Case Medical Center in Cleveland, Ohio. “This new product will benefit my patients and my practice with simpler, more consistent lead anchoring.”
According to the National Center for Health Statistics, pain is the most common reason Americans seek medical treatment, and an estimated 26 million Americans experience frequent back pain. Tens of thousands of patients with chronic pain have found that SCS systems help them manage their pain. Spinal Cord Stimulation is a reversible therapy that manages pain through an implantable pulse generator and external devices that control therapy and charge an implant.
Boston Scientific’s Precision Plus SCS System, powered by SmoothWave™ Technology, masks pain signals by delivering independently controlled pulses of electricity through SCS leads. Anchors are designed to secure leads and minimize unwanted migration.
“With approval and launch of the Clik Anchor, we have added six new products to our Neuromodulation portfolio in the past year,” said Michael Onuscheck, Senior Vice President and President of Boston Scientific’s Neuromodulation Division, a leader in microelectronic implantable technologies used to treat chronic neuropathic pain. “The Clik Anchor complements our SCS percutaneous leads portfolio, and gives physicians the most comprehensive array of lead options in the market.”
The Precision Plus SCS System is indicated as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
The U.S. Food and Drug Administration approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.
The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to create a bypass without shutting off the blood flow. It consists of a small platinum ring and a hand piece connected to a surgical laser and suction tubing.
Standard bypass surgery in the brain requires clipping the artery to halt blood flow during the procedure. The surgery is not considered safe for about 1,000 patients annually in the United States because temporarily shutting off their blood flow would put them at high risk of stroke. The group includes patients ages 13 and older who have an enlarged, weak area in a brain artery (cerebral aneurysm), tumors at the base of the skull that could impact blood flow in brain arteries, or other issues that could complicate conventional surgery.
“The ELANA Surgical Kit may help those with a rare condition for whom there previously was no treatment option,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
To create the bypass, a surgeon sutures the ring and a section of replacement blood vessel onto the surface of the affected artery. Once attached, the surgeon tunnels the tip of the laser handpiece down the open end of the replacement blood vessel until the tip of the laser touches the ring.
The laser then cuts a circular hole in the affected artery, and suction removes the cut tissue. The process is repeated with a second replacement blood vessel. Once both replacement blood vessels are in place, the open ends of the two replacement blood vessels are sutured together to complete the path around the aneurysm or tumor.
The FDA approved the ELANA Surgical Kit as a Humanitarian Use Device, which is a device that is designed to treat or diagnose a disease or condition in fewer than 4,000 people in the United States each year. To obtain approval for humanitarian use, a company must demonstrate the safety of the device and that the probable benefit outweighs the risk of illness or injury. The company must also show that no comparable devices are available to treat or diagnose the disease or condition.
The clinical data in support of approval demonstrated that a bypass created using the ELANA kit had the same types and similar incidences of adverse events reported in the medical literature as conventional bypass procedures.
A patient should not undergo laser bypass surgery using the Elana kit if the arteries show signs of arteriosclerosis or calcification at the surgery site, the walls of the affected artery are thicker than a carotid artery, or have an abnormality. Bypass surgery with the Elana should not be done on an aneurysm or on vessels other than large (> 2.5 mm), intracranial arteries.
In some cases, the laser does not completely cut through an artery wall leaving a tissue flap that potentially could block blood flow and result in an embolism. As part of the approval, the FDA required a post approval registry study to collect performance information about the kit, including flap retention rate, mortality, and stroke.
Source: U.S. Food and Drug Administration