Sorin Group to Leverage Greatbatch’s MRI Technology for Sorin Group CRM Devices

Friday May 16, 10:11 am ET

CLARENCE, N.Y.--(BUSINESS WIRE)--The Sorin Group and Greatbatch announced today the execution of a letter of intent that will leverage Greatbatch’s eM-able™ technology in the Sorin Group’s future cardiac rhythm management (CRM) systems.

Catherine Picard, vice-president of R&D at Sorin Group said, "We are very excited by the opportunity to leverage Greatbatch’s eM-ableTM technology to accelerate our MRI program and deliver MRI conditional systems to patients and physicians worldwide in the shortest possible time."

Many patients implanted with a pacemaker or a defibrillator (ICD) cannot take advantage of an MRI scan, because energy from this life-saving technology can change how a device controls the heart, damages the device or injures the heart tissue surrounding it.

MRI conditional approved devices are critical to allow patients with active implantable medical devices (AIMDs) to safely have an MRI for diagnostic evaluation.

"As we see more patients receive AIMD’s the need for MRI conditional devices will continue to grow, said Mauricio Arellano, senior vice president of Greatbatch’s CRM & Neuromodulation business. "This potential partnership with Sorin Group would meet that demand by securing our technology in their next generation devices."

Stryker Sees Fewer Hip Procedures in 2008

Thursday May 15, 6:31 pm ET

Stryker share slip as company said sees fewer hip resurfacing procedures in 2008

NEW YORK (AP) -- Shares of orthopedics manufacturer Stryker Corp. fell Thursday after the company indicated that fewer hip surfacing procedures would be conducted this year than it previously forecast.

This week, Stryker notified its partner, U.K.-based medical technology company Corin PLC, that based on current inventory, it will not order additional Cormet hip resurfacing devices from Corin until December.

Stryker in April had confirmed its order plans with Corin, saying it expected implant procedures to accelerate in the second quarter once a training program picked up. However, Stryker has now doesn’t expect procedures to meet its prior forecasts.

Goldman Sachs analyst Lawrence Keusch said he is not surprised by Stryker’s announcement given that the investment house’s recent survey of U.S. orthopedic surgeons indicate that hip resurfacing procedures will be modest.

Keusch maintained his "Neutral" rating and $70 price target on the stock.

Stryker shares fell $1.31, or more than 2 percent, to $62.88.

Who’s Really Winning The Heart-Stent Race?

May 14, 2008

By James Brumley. James Brumley is a freelance writer and registered investment advisor.

On Tuesday we saw the corporate equivalent of a water balloon fight within the tiny little world of coated heart stent makers. All the companies that make these specialized medical devices came out with news trying to "one up" the competition.

The back-to-back announcements weren’t a coincidence. The major names in the industry were all presenting at the EuroPCR Conference in Barcelona, Spain. With the conference and ensuing contest now over, and the dust settling, it’s safe to come out of hiding to see which piece of news actually meant something. A stent is a tube inserted into an artery to prop it open either during or after surgery. There is a surprisingly lucrative market for the little devils. (For information on valuation of drug companies, check out Measuring Medicine Makers.)

Three-Way Tie?

According to a recent study, Abbott Laboratories’ (NYSE:ABT) Xience V stent is superior to its competing Taxus stent, in that its use is associated with diminished heart attack risk at the one-year, and now two-year milestones. Of course, the study was sponsored by Abbott, so there may have been room for "interpretation".

The Xience stent is not yet on the market in the United States, but is being sold in Europe. Some analysts expect to see Xience stents approved by the Food and Drug Administration (FDA) in the middle of this year.

In a separate press release on Tuesday, Boston Scientific (NYSE:BSX) touted solid two-year efficacy and safety results from the same Taxus stent that Abbott said it outdid. The difference between this study and Abbott’s is this research was done independently. The same two-year study also confirmed good results from Boston Scientific’s Promus stent - which is also known as a Xience V stent. Déjà vu? No, you read that right.

Boston Scientific’s Promus is the same stent as Abbott’s Xience. The company is licensed to sell Abbott’s stent under a different name. In the meantime, the Taxus-Liberte stent is approved in Canada, Europe, and other countries, and is (right now anyway) the best-selling heart stent in the U.S.

Not to be outdone, Medtronic (NYSE:MDT) on Tuesday released four-year efficacy data on its Endeavor II drug-eluting stent. The first-generation Endeavor stent was approved for use in Europe in October and for use in the U.S. in January. However, the Endeavor II looks ready to compete with the other next-generation stents if it’s approved. To support its case, Medtronic is sponsoring a comparative study of its Endeavor and Abbott’s Xience V. (To analyze the future prospects of biotechnology companies try using the discounted cash flow approach, read Using DCF In Biotech Valuation.)

For these three medical device giants, jockeying for market share is nothing new. Is there a freshman in the group that could reshape the industry? Yes, but no. Keep reading.

Raising the Bar on the Up-&-Comers

The bitter irony of this horse race is the company that may actually be the best got a late start out of the gate. Stent manufacturer XTENT (Nasdaq:XTNT), the youngster in the arena, announced strong six-month test results with its Custom NX stent on Tuesday. Though the company is fairly new to the stent world, its Custom NX stent may have one edge on the other coated stents mentioned above because they can be custom-sized for each patient.

So XTENT is being ushered to the front of the line? Not so fast. A couple of years ago XTENT may have been able to sail through the FDA’s medical device approval process. The bar has been raised since then.

Though an adjustable stent is a clear benefit, the FDA is on the verge of requiring at least two years of safety data on new coated stents. This standard would create barriers to entry, and apply to new stents developed by the companies we’ve already discussed, but at least they’ve got something on the market already, not to mention plenty of research history on their new devices. XTENT has nothing except time on its hands.

Bottom Line

Unfortunately, being first may be more important than being the best. Being both would be ideal. In that light, Abbott seems like the winner of this game. Abbott’s got what many believe is a better product already selling in Europe, and what will be the preferred stent in the U.S. if it’s approved by the FDA. The fact that Boston Scientific’s future stent of choice (Promus) just happened to be a licensed version of the competition’s product speaks volumes. The salt in the wound is that Abbott acquired the Xience technology when it acquired part of Boston Scientific a couple of years ago.

This is a $4 billion market annually, with half of that figure coming from the U.S. There’s likely room for all the players when-and-if they can commercialize their latest R&D. Even XTENT is likely to have a day in the sun, but I think Abbott is going to have its day first, and Boston Scientific is along for the ride.

Medtronic Begins Cutting Jobs

Thursday, May 15, 2008 - 1:25 PM CDT

Minneapolis / St. Paul Business Journal - by Carissa Wyant Staff Writer

Fridley-based medical device maker Medtronic (NYSE: MDT) said in May that it would cut about 1,100 positions as it realigns its business on a global basis - and about 350 jobs would be cut locally. Medtronic employs approximately 8,000 workers in the Twin Cities, at its headquarters and in its cardiac rhythm disease management and neurological businesses.

Medtronic currently employs about 39,500 worldwide. Medtronic said that the cuts would come from its businesses that are no longer growing at previous rates. A spokeswoman for the company said the cuts would be complete by June

Covidien to acquire Pinyons Medical Technology Assets

,May 14, 2008 - 9:27 AM CDT

St. Louis Business Journal - by Matt Allen Wednesday. Covidien is acquiring all assets related to Pinyons Medical Technology Inc.’s POWRSyringe Injector and POWRSyringe Monitor, which are handheld, manual injection and inflation devices, for an undisclosed amount.

Covidien said Wednesday it will immediately obtain all assets related to the POWRSyringe Injector and POWRSyringe Monitor product lines, including all intellectual property, current and future product designs and regulatory filings and approvals.

The devices, which have received clearance from the U.S. Food and Drug Administration, facilitate manual x-ray contrast media injections during angiography procedures performed in the cardiac catheterization laboratory and interventional radiology suite.

Park City, Utah-based Pinyons Medical Technology Inc. designs, develops, and manufactures medical devices.

Bermuda-based Covidien (NYSE: COV, BSX: COV), formerly known as Tyco Healthcare, operates Covidien Imaging Solutions, also known as Mallinckrodt, which is located in St. Louis and provides medical imaging technology. It was spun off from Tyco International Ltd. (NYSE: TYC) in 2007.

Becton Dickinson spent $250,000 lobbying U.S. Congress in 1Q

Monday May 12, 5:18 pm ET

Becton Dickinson spent $250,000 lobbying Congress in first quarter of 2008

WASHINGTON (AP) -- Medical device and supplies maker Becton Dickinson spent $250,000 lobbying Congress in the first quarter of the year.

The company lobbied Congress on the risks and costs of hospital-related bacteria infections. Becton Dickinson markets a line of medical tests and supplies designed to detect and prevent infections.

The company also lobbied for legislation that would increase what the government’s Medicare program pays for diagnostic tests. Medical device companies have argued in recent years that health care providers do not pay enough for tests that help prevent costly diseases.

Company lobbyists also advocated for permanent tax credits to encourage companies to invest in research and development spending.

The Franklin Lakes, N.J.-based company disclosed its lobbying expenditures in a form filed April 21 with the Senate office of public records.

Baxter Healthcare Spent $730,000 Lobbying the U.S. Federal Government in First Quarter of 2007

WASHINGTON (AP) -- Drug and medical device maker Baxter Healthcare Corp. spent $730,000 lobbying the federal government on health care issues in the first quarter.

The company lobbied on funding for the Food and Drug Administration, which reviews the safety and effectiveness of all U.S. pharmaceuticals.

Lobbyists also pushed for more funding for kidney disease awareness. Baxter markets the blood thinner heparin which is used by kidney patients to prevent clotting during dialysis.

Earlier this year Baxter recalled all of its heparin vials due to contamination that has been linked to 81 deaths and hundreds of allergic reactions. The FDA has said it suspects the problems stem from a contaminant found in raw heparin imported from China. But Chinese officials say it is too early to tell and have accused the U.S. of blocking its attempts to investigate the problems.

The company also lobbied on free trade agreements with Korea and international protections for drug patents.

Given Imaging Receives Permanent Medicare Funding for PillCam^(R) SB in Australia

Thursday May 15, 12:00 am ET

Funding Application Supported by Largest Body of Clinical Data on PillCam Capsule Endoscopy

YOQNEAM, ISRAEL--(MARKET WIRE)--May 15, 2008 -- Given Imaging Ltd. (NasdaqGM:GIVN - News) today announced that the Australian Government Department of Health and Ageing has approved permanent Medicare funding for capsule endoscopy of the small bowel. Capsule endoscopy has been interim Medicare funded in Australia subject to data collection since May 2004. Medicare is the scheme that gives all Australian residents access to subsidized health care.

Private health fund premiums to soar

May 20, 2008 12:00am By Sue Dunlevy Daily Telegraph Sydney

PRIVATE health fund premiums could skyrocket by an extra $230 a year as health ministers debate whether insurers should pay the full cost when their members use a public hospital bed.

Federal Health Minister Nicola Roxon says it’s time to look at whether health funds should have to increase the amount they pay when their members use a public hospital bed.

Describing the amount health funds pay as "contentious", she said it was time to look at making sure "we are getting full value".

Health funds currently pay just $310 a day when their members use a public hospital bed, that’s a discount of up to $490 on the true cost of providing such a bed, a spokeswoman for NSW Health Minister Reba Meagher said.

But health funds claim if they had to pay the full cost for a bed it would drive up premiums.

It would be a double whammy for funds, which are already predicting premium rises will flow from a Budget measure to exempt people earning under $100,000 from a tax levy forcing them to take out cover.

This policy is expected to see 485,000 people drop their cover and put pressure on premiums.

The small amount paid by health funds for the public hospital beds has state health ministers complaining they are effectively subsidising health fund members.

Ms Roxon confirmed the issue had been raised by her state colleagues.

"To build a modern health system, we must get the balance between public and private health right," she said.

But Australian Health Insurance Association chief Dr Michael Armitage says if health funds had to pay the true cost of a public hospital bed it could add 5 per cent to members’ premiums, or about $230 a year.

And fund members in NSW, where many privately insured patients use public beds, could face even higher rises.

Any such policy would strike at the heart of the Medicare compact which guarantees every Australian free access to a public hospital, Dr Armitage said.

The Health and Hospital Reform Commission established by the Rudd government is expected to look into whether health funds should pay more when their members use the public system.

State governments are pushing for a discussion on the issue as part of the negotiations over the next five year hospital agreement.

Any move to make health funds pay more could see the Commonwealth Government hit financially.

If premiums rose they would have to fund 30 per cent of any such rise through the 30 per cent tax rebate offered to health fund members.

Labour’s $160m injection for health

Monday May 19, 2008 New Zealand Herald

By Martin Johnston

The Government is pouring an extra $160 million into elective surgery in a pre-election push to bolster the public health sector.

The new money was revealed in a pre-Budget announcement yesterday by Health Minister David Cunliffe, in the company at the Starship hospital of 12-year-old Alex Beggs. The Kohimarama girl last year underwent spinal surgery, an area to be boosted by the funding.

Alex said the money would allow more operations like hers to be performed. "It’s really good because they need to get them done."

However, National’s health spokesman, Tony Ryall, said it was "guilt money" from Labour after 40,000 people were removed from hospital waiting lists over two years.

Sixteen of the country’s 21 district health boards are compliant with the Government’s policy of seeing the sickest patients first and offering surgery only to those who can be treated within six months. But problems exist, such as long waits for some heart surgery that are considered unacceptable by cardiologists.

Alex’s father, airline pilot Graeme Beggs, although grateful his daughter was treated successfully for spinal curvature, said he was cynical at the timing of the funding increase in the months before the election. "It should have been years ago."

Mr Cunliffe denied the money was a tactic to buy votes at this year’s election, pointing to the 2006 increase in electives funding which was separate from the electoral cycle.

"This is a determined effort to make sure the rate of electives growth is faster than the rate of population growth.

"We are now well ahead of population growth in electives performance. In 2006-2007 we had a 6.3 per cent increase [in patient discharges] and we are up to 207 discharges for 10,000 people, which is higher than 199 in 2001-2002 when we first got the data."

The new money is expected to increase the number of hospital inpatients receiving treatment for non-urgent conditions by around 5000 a year.

The number of first specialist assessments will rise by about 20,500 a year and the number of outpatient procedures by 3500, under a new "ambulatory electives initiative" (although only half of this increase has assured funding beyond June 2010).

This initiative will enable more patients to be seen in hospitals and permit some GPs to do more work usually done by specialists, like treating certain skin conditions and ordering more tests like CT scans.

The College of GPs president, Dr Jonathan Fox, said this initiative should cut delays for patients.

"We’ve been working towards this for a long time, advocating that specialist GPs in primary care get access to high-tech diagnostics and other specialist assistance that will speed up eventual treatment."

District health boards spokesman David Meates said the initiative should improve the flow of patients between general practice and hospitals.