Medtronic Inc., with the help of Alnylam Pharmaceuticals Inc., announced its plans to develop an implantable pump to treat Huntington’s disease. The combination device is expected to deliver Alnylam’s RNA interference (RNAi) therapy via Medtronic’s pump. RNAi is a process that naturally happens in cells and is suspected to turn off genes that cause certain diseases. Medtronic plans on marketing the device in Europe and then in the United States. The two companies have been collaborating since 2005 on research leading up to the development of the technology.
Huntington’s is a devastating degenerative disease that causes the deterioration of certain nerve cells in the brain. If the technology is successful in treating this disease, it’s possible that Medtronic and Alnylam will develop similar combination devices to treat neurodegenerative disorders such as Parkinson’s.
There have been a number of problems with infusion pumps in recent years. Now Baxter finds itself with another one on its hands. But this one appears to center on faulty data, not a technological issue. A Class I recall was announced last week, and FDA issued an update on Friday.
The firm found that some repair, inspection, and test data sheets, which included electrical safety data for the pumps, were falsified. That means it is possible that some pumps sent away for service that patients believed were fixed in fact weren’t.
Patients are advised to return affected pumps to Baxter for repeat servicing. The models affected are Baxter Colleague and Flo-Gard volumetric infusion pumps, model numbers 2M8151 and 2M8153, Colleague CX volumetric infusion pumps, model numbers 2M8161 and 2M8163, and Flo-Gard volumetric infusion pumps, model numbers 2M8063 and 2M8064.
Medtronic Inc. (Minneapolis) announced it will buy Kyphon Inc. (Sunnyvale, CA) for $3.9 billion. The purchase will expand Medtronic’s spinal portfolio to include the treatment of older patients with spinal conditions. The addition of Kyphon will give patients of all age ranges access to more minimally invasive spinal treatments. Months ago, Medtronic CEO Art Collins said that the company’s growth was dependent upon having a diverse line of products.
Once the acquisition is completed, Medtronic will also drop the lawsuit it filed against Kyphon over four patents involving catheters and spinal treatments.
During the past year, a lot of attention has been given to the potential link between head injuries in NFL players and the serious effects it may cause later in life. One pro football team will become the first to try out a technology that could help identify brain injuries sooner than later. This season, the Oakland Raiders will be using a portable and cordless computed tomography (CT) scanner to aid in identiying head injuries onsite. NeuroLogica Corp’s (Danvers, MA) CereTom scanner instantly generates images of the neck and head in minutes to help diagnose brain injuries and bleeding. It can also reveal injuries to the elbows, knees, and ankles. After the scan is completed, it can be wirelessly transmitted to a doctor for diagnosis.
As a side note, the NFL formed a traumatic brain injury committee and announced earlier this year that it’s planning on looking at the potential link between concussions and depression in players.
An FDA task force on nanotechnology does not see a need at this time to add more regulations regarding use of nanotechnology in medical devices, but its report recommends that the agency consider developing guidance. It emphasizes that there is a need for ensuring transparent, consistent, and predictable regulatory pathways.
Specifically, the task force would like to see guidance that would clarify what information to give FDA about products, and when the use of nanoscale materials may change the regulatory status of particular products.
This is the prudent and correct response. At last year’s public meeting of the task force, some consumer groups wanted a ban on the use of nanotechnology in FDA-regulated products until more research could be done, or for there to be more regulations controlling nanotechnology’s use. But in the case of devices, the PMA and 510(k) processes already require information about what a device is made of, so FDA already has the authority to make device companies perform toxicology and other tests and provide data showing nanomaterials are safe. What industry needs is clarification about how this process should work, not a new process. And that’s what the guidances are for.
A group of healthcare organizations are demanding that FDA require the labeling of PVC devices that contain DEHP. A petition sent by Health Care Without Harm (HCWH) states that exposure to the toxic chemical can cause a disruption in the development of the male reproductive tract, along with harming vulnerable patients such as those on dialysis. For years there has been a debate about whether or not DEHP is harmful. The European Union has already announced mandatory labeling of medical devices that have DEHP, and it currently bans DEHP and other phthalates from toys and cosmetic products. HCWH says that the proper labeling of devices will allow hospitals to switch to safer alternatives.
In 2002, FDA issued a warning about the use of DEHP in medical devices, but took no action to enact mandatory labeling.
The diagnostics industry wants to get in on merger mania, too.
Siemens announced that it will buy Dade Behring for about $7 billion, a move that would bring two firms from opposite ends of the diagnostics sector together. Siemens is known for its high-tech imaging systems, while Dade Behring is known for its clinical laboratory testing equipment. Dade Behring’s specialties include routine chemistry testing, immunodiagnostics, hemostasis testing and microbiology. This is the third major diagnostics acquisition Siemens has made recently. Last year it acquired Bayer Diagnostics and Diagnostics Products Corp. The goal, Siemens says, is to “become the global leader in full-service diagnostics, offering imaging diagnostics, clinical laboratory diagnostics and healthcare IT solutions - from a single source and along the entire value chain.” Without resorting to bribery, presumably.
This again raises the question of who will buy Abbott’s diagnostics business now that GE doesn’t want it. Siemens, with all its other acquisitions, wouldn’t seem to be a player for it either, and there aren’t many other diagnostics firms with the size to pull it off.
Shares of EV3 Inc. (Plymouth, MN) and FoxHollow Technologies (Redwood City, CA) both surged more than 10% yesterday after the firms announced plans to merge, reports the Star Tribune of Minneapolis. The deal would come to about $780 million. The market capitalization of the two up-and-coming firms would combine for a value of about $1.7 billion, and its annual sales would total about $600 million.
EV3 and FoxHollow are both major innovators in endovascular technology, and both firms have been touted highly by Wall Street analysts for years. The company’s combined product portfolio will include atherectomy and thrombectomy devices, PTA balloons, stents, embolic protection devices, infusion catheters and wires, embolic coils and liquid embolics.
In case you were wondering whether there were more multibillion-dollar deals out there in the device industry, the answer is yes. This morning, reports Bloomberg News, Teleflex Inc. (Limerick, PA) announced it would buy Arrow International Inc. (Reading, PA) for $2 billion. Arrow makes a variety of catheter-based devices for critical and cardiac care. Multi-industry conglomerate Teleflex, which has gone on a huge acquisition binge this year, is offering $45.20 per share, about 20% more than Arrow’s closing stock price on Friday.
The Star Tribune is reporting that Medtronic Inc. has reached a settlement to end more than 1400 lawsuits related to alleged defects in its defibrillators. The company will be paying more than $75 million as part of the settlement, which is also dependent upon Medtronic’s ability to get 90% of the claimants to sign the agreement, the article notes. The claims against the company reportedly said that Medtronic hid battery defects in its defibrillators.
 As noted in the blog earlier this week, Boston Scientific agreed to pay $195 million to settle a class-action lawsuit related to Guidant’s defective defibrillators.
