dijous, 27 d’octubre del 2016

Study uses nasal tissue to repair damaged knees

generic-hospital-or-1x1(Reuters) – Doctors might one day be able to harvest cells from patients’ noses to produce cartilage that can be transplanted into damaged knee joints, a small experiment suggests.

Researchers tested a new technique for repairing what’s known as articular cartilage, the tissue that covers the ends of bones where they come together to form joints. When articular cartilage is damaged by injury or normal wear and tear, it can result in joint pain and limited mobility.

Because the experiment only included 10 adults who were followed for just two years, it’s impossible to say for sure whether this procedure would be safe or effective with widespread use. But the results are promising enough to merit more testing, said study co-author Ivan Martin of the University of Basel in Switzerland.

“We have developed a new promising approach to the treatment of articular cartilage injuries,” said Martin said by email. “Before this can be offered to patients as a standard treatment, obviously it needs to be tested in larger patient cohorts and in randomized and controlled trials with long-term assessment of clinical outcome.”

Previous research has found cells extracted from the septum, cartilage tissue in the nose, can be used to grow new cartilage in a lab, Martin said. With the current experiment, researchers successfully implanted this lab-grown tissue into knee joints for the first time, he said.

To do this, researchers first performed a minimally invasive procedure using local anesthesia to harvest a small specimen, about 6 millimeters or a quarter of an inch, of tissue from the nasal septum.

Next, they grew the harvested cells in a lab for two weeks, then cultured them for another two weeks on a scaffold made of what’s known as collagen membrane to grow thin sheets of cartilage measuring 30 mm by 40 mm, or about 1.2 inches by 1.5 inches.

Researchers trimmed these grafts to the right shape to replace the damaged cartilage removed from each patient’s knee joint, then implanted the replacement tissue.

Two years after reconstructive surgery, most recipients reported improvements in pain, knee function and quality of life, researchers report in The Lancet.

MRI scans at two years also showed the growth of new tissue similar to native knee cartilage around where the replacement tissue was implanted, the study found.

Researchers didn’t see any adverse reactions or dangerous side effects.

Every year, around 2 million people in the U.S. and Europe alone are diagnosed with damage to articular cartilage because of injuries or accidents, the researchers note.

Because the tissue doesn’t have its own blood supply, it has limited capacity to repair itself once damaged, leading to degenerative joint conditions like osteoarthritis.

Traditional methods to prevent or delay onset of cartilage degeneration don’t create the healthy cartilage needed to endure the forces of everyday movement, the authors contend.

Efforts to use patients’ own healthy articular cartilage cells from a healthy joint to repair damaged knee tissue haven’t been able to reliably restore function over the long term, the researchers argue.

“In my eyes, the major advantage (of the experimental procedure using nasal tissue) is that there is no need to obtain cartilage from within a healthy joint,” said Dr. Nicole Rotter of Ulm University Medical Center in Germany, author of an accompanying editorial.

“Potential harms include side effects to the new donor site, the nose, such as deformities of the nose and functional problems such as nasal obstruction,” Rotter added by email. “These negative side effects can be avoided with an appropriate surgical technique to obtain the biopsy, meaning this is a surgery that should be done by a person with expertise in nasal surgery such as an otorhinolaryngologist.”

Beyond that, more research is needed to see how this procedure works in the knee joint over a longer period of time, Rotter added by email.

“Long term stability and integrity need to be investigated, as a potential risk could be that these transplants are not stable in the long run,” Rotter said.

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Stryker shares strong on street-beating Q3

StrykerShares in Stryker (NYSE:SYK) stayed steady today after the medical device maker met expectations on Wall Street with its 3rd quarter results.

The Kalamazoo, Mich.-based company posted profits of $355 million, or 94¢ per share, on sales of $2.83 billion for the 3 months ended September 30, with bottom-line growth of 17.9% as sales grew 17.1% compared with the same period in the prior year.

After adjusting to exclude 1-time items, earnings per share were $1.39, a minimal 2¢ ahead of where The Street had expected. Revenue beat The Street’s expectations, which was looking for $2.81 billion.

Shares stayed steady today, down a meager 0.15% to close at $109.72.

“Our 3rd quarter results again demonstrate our ability to consistently deliver strong organic sales growth at the high end of med tech. Our acquisitions are performing well and contributed to solid overall earnings performance,” CEO Kevin Lobo said in prepared remarks.

Stryker said it expects to post adjusted EPS of $5.75 to $5.80 for the full year, up from a prior target of $5.70 to $5.80. For the 4th quarter, Stryker expects to see adjusted EPS between $1.73 and $1.78.

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Varian Q4 release sees shares slump amid new deal with McKesson, CFO retiring

Varian wins FDAclearance for Nexus DR digital X-rayVarian Medical (NYSE:VAR) today saw shares slump after releasing mostly positive Q4 earnings, while also announcing it inked a new deal with McKesson Specialty Health as well as the retirement of its current CFO Elisha Finney.

The Palo Alto, Calif.-based company posted profits of $117.8 million, or $1.25 per share, on sales of $912.5 million for the 3 months ended September 30, for bottom-line growth of 18.9% on sales growth of 11.6% compared with the same quarter last year.

Adjusted to exclude 1-time items, earnings per share were $1.38 per share, 3¢ ahead of the The Street’s consensus, where analysts were looking for sales of $882 million.

For the year, the company reported profits of $402.7 million, or $4.19 per share, on sales of $3.2 billion. That works out to a 2.3% bottom-line slide while sales grew 3.8% compared with last year.

After adjusting to exclude 1-time items, earnings per share were $4.68, a solid 31¢ below what analysts on Wall Street were looking for. The Street expected to see revenue of $3.24 billion, which Varian slightly missed.

VAR shares slipped in trading today, down 4.4% to close at $89.95.

“The company finished the year on a strong note with solid growth in revenues and margins for both of its major businesses. For the 4th quarter, total company gross margin increased by nearly four percentage points over the year-ago quarter.  Weak oncology orders in EMEA, where we had tough year-ago comparisons, offset gross order growth in the Americas and in Asia,” CEO Dow Wilson said in prepared remarks.

For the 1st quarter of 2017, the company expects to see non-GAAP earnings per share between $1.03 and $1.07 per diluted share, with revenues up 1-2%. For the full year, Varian said it expects to see between 3% and 4%.

Varian said it inked a 3-year strategic agreement with McKesson Specialty Health for the deployment and servicing of Varian advanced radiotherapy equipment and software at oncology treatment sites.

The deal will place 7 Varian TrueBeam an 5 VitalBeam medical linear accelerators at McKesson sites, and will position the 2 companies to collaborate to establish interoperability between McKesson’s iKnowMedSM electronic health record system and Varian’s Aria oncology information system.

“McKesson Specialty Health and The US Oncology Network offer robust, comprehensive practice management capabilities, value-based care expertise, and state-of-the-art technology solutions to its affiliated practices, providing support as they navigate today’s challenging healthcare landscape. Combined, Vantage Oncology and The US Oncology Network support more than 1,300 affiliated physicians and approximately 400 affiliated sites of care. Bringing them together earlier this year and now executing this strategic agreement with Varian will help our affiliated practices simultaneously enhance clinical capabilities, workflow for physicians, and the quality of patient care while improving the cost-effectiveness of their operations. The specialized hardware, service offerings and roadmap for interoperability with iKnowMed gives clinicians greater efficiency and increased quality of patient care benefits,” McKesson Specialty Health U.S. oncology network and practice management prez Kirk Kaminsky said in a press release.

“We are honored by the long-term commitment McKesson Specialty Health is making in Varian equipment and technology as part of this agreement. Our companies share a common goal to develop and deliver the highest level of care. Through this strategic agreement, we are increasing the ability of patients to access the most advanced treatments in their fight against cancer,” Varian oncology systems biz prez Kolleen Kennedy said in prepared remarks.

Varian Medical said its CFO Finney will be retiring form her position, though will remain on with the company until a successor is named, which the company is hopeful will occur during the fiscal year 2017. The company said it has begun searching for a replacement.

“For our company and for our investors, Elisha has been an intelligent, trusted and energetic leader that all of us count on to help deliver winning results. With her help and guidance, we have achieved a sustained, decades-long record of growth in revenues and profitability.  Her passion and competitiveness have been driving forces for the entire company.  She leaves a great track record to build upon.   We have been very fortunate to have Elisha on our management team,” CEO Wilson said in a press release.

“I am fortunate and proud to have spent virtually my entire career at a company that has the mission of saving lives. After nearly 29 years at Varian and nearly 18 years as CFO, I am excited about spending more time with my family and about the prospect of serving on boards of other companies.  We have grown tremendously since the last Varian spin in 1999 and the planned spin-off of the Imaging Components business presents a natural time to transition.  It has been a privilege to be part of a dedicated, passionate team whose talent and professionalism have made Varian a global power in the fight against cancer,” Finney said in a prepared statement.

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Teleflex shares slump over 10% despite posting Street-beating Q3 EPS

TeleflexShares in Teleflex (NYSE:TFX)  fell today despite the medical device maker meeting earnings per share expectations on Wall Street in its 3rd quarter.

The Wayne, Penn.-based company posted profits of $66.3 million, or $1.40 per share, on sales of $455.6 million for the 3 months ended September 25. The company posted bottom-line growth of 7.7% while sales grew 2.7%, compared with the same period in the previous year.

After adjusting to exclude 1 time items, earnings per share were $1.80, 2¢ ahead of the consensus on The Street, with analysts expecting to see slightly higher sales of $461 million.

TFX shares sunk on the release, dropping 11.5% to close $18.08 down at $139.41.

“Third quarter sales were below our expectations, driven in part by weakness in certain Asian emerging markets, continued softness in oil-based Latin American economies, the timing of distributor purchases which negatively impacted some of our North American product lines and a slower than initially anticipated contribution from revenue associated with new products. Despite the softness in revenue, non-revenue dependent financial leverage allowed the company’s adjusted earnings per share performance in the third quarter to exceed our expectations. Based on the performance during the third quarter, as well as our expectations for the remainder of the year, we are lowering our full year 2016 GAAP and constant currency revenue growth ranges. We now expect our full year 2016 GAAP and constant currency revenue to grow between 2.4% to 2.8% and 3.4% to 3.8%, respectively. Despite the reduction in revenue growth expectations, we are maintaining our full year GAAP earnings per share range of $5.34 to $5.41 and increasing our full year adjusted earnings per share range to be $7.25 to $7.34,” chair & CEO Benson Smith said in a press release.

Teleflex lowered revenue guidance for the full year 2016, expecting to see revenue increases of between 2.4% and 2.8% over prior year revenue.

The company reaffirmed its earnings per share guidance for the full year, expecting to see GAAP diluted earnings per share between $5.34 and $5.41 for the year. Non-GAAP earnings per share are expected to be between $7.25 and $7.34.

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NuVasive wins MR-safe indication from FDA for Magec spine system

NuVasiveNuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA clearance for its Magec system, now indicated for safe use with 1.5 tesla magnetic resonance imaging devices.

The San Diego, Calif.-based company’s Magec system is a magnetically controlled growth modulation system cleared by the FDA for pediatric spinal deformity, which the company claims is a 1-of-the-kind device on the market

“Having clear, defined guidance for conditional MRI compatibility with Magec helps alleviate uncertainty that may have limited surgeons from using the innovative Magec system. This clearance opens up the door for more patients and their families to benefit from this life changing technology,” Dr. Suken Shah of the Nemours/Alfred I. duPont Hospital for Children said in prepared remarks.

The company said that the clearance will allow early onset scoliosis patients access to MRIs, something their treatment often requires multiples of. NuVasive said that, in the past, a lack of guidance on MR conditions was a hurdle for surgeons in adopting the Magec treatment.

“As the only noninvasive growth modulation system on the market, this clearance is a key milestone in overcoming a known barrier in the treatment of children with EOS. NuVasive is consistently on the cutting-edge of the latest treatment options and we work diligently to bring that innovation to as many patients as possible around the world,” prez & CEO Jason Hannon said in a press release.

In August, NuVasive said the Centers for Medicare and Medicaid Services granted a new technology add-on payment for magnetically controlled growth rods, including the company’s Magec system.

Earlier in August, NuVasive significantly lifted its guidance for the year after reporting 2nd quarter earnings that topped Wall Street’s expectations and saw sales and revenue grow significantly from last year’s 2nd quarter.

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Abiomed shares dip on Q1 release, despite FDA IDE win

AbiomedShares in Abiomed (NSDQ:ABMD) fell today after the medical device maker missed the Street’s expectations for its 2nd quarter, despite touting an FDA IDE win for a trial of its Impella CP heart pump.

The Danvers, Mass.-based company posted profits of $8.9 million, or 21¢ per share, on sales of $103 million for the 3 months ended September 30. That amounts to bottom-line growth of 14.7% on sales growth of 34.8% compared with the same period in 2015.

Earnings per share and revenue were just below consensus on The Street, where analysts expected to see sales of $103 million and earnings per share of 24¢.

“This quarter’s historical achievement with Japanese PMDA approval reflects years of regulatory execution. Additionally, today we are announcing significant new milestones: Impella heart pumps assigned to heart assist system implant, MS-DRG 215 and FDA approval for our feasibility STEMI study, “DTU”, for a new patient population. I am proud of our team’s ability to consistently accomplish our strategic initiatives and execute our tactical plan as Abiomed builds the field of heart recovery,” CEO Michael Minogue said in prepared remarks.

The company said it is maintaining previously released 2017 revenue guidance of $435 to $445 million, with GAAP operating margins between 18 and 20%.

ABMD shares are trading at $100.75 as of 3:09 p.m. EDT, down approximately 9.7%.

The company touted an FDA IDE win, gaining approval for a prospective feasibility study of its Impella CP heart pump for unloading the left ventricle prior to primary percutaneous coronary intervention in patients presenting ST segment elevation myocardial infarction without cardiogenic shock.

“As clinicians and scientists, we appreciate the FDA’s approval of this feasibility study. And we are excited to further investigate whether mechanically reducing the workload of the heart before reopening a blocked coronary artery reduces myocardial damage and the subsequent development of heart failure,” Dr. Navin Kapur said in prepared remarks.

The trial will explore the feasibility and safety of the device, and lay the groundwork for a future trial looking to measure the impact unloading could have on infarct size related to reperfusion injury.

“The majority of patients with large myocardial infarction involving the front wall of the heart develop congestive heart failure within five years. The process of reperfusion with primary PCI should be investigated with new therapeutic strategies targeting myocardial reperfusion injury, which may improve clinical outcomes for patients,” Dr. William O’Neill said in a prepared statement.

Currently, Abiomed’s Impella heart pumps are not approved for use in STEMI patients without cardiogenic shock, the company said. The STEMI patient segment “is contributing to the growing heart failure population and represents a potential new patient indication that may benefit from Impella pump unloading the left ventricle,” the company added.

The prospective, multi-center feasibility study is slated to enroll up to 50 patients at 10 sites with an expected initiation date in the 1st half of 2017, and a length of 18 months. Primary endpoint for the study will be infarct size as a percent of left ventricular mass at 30 days post-PCI.

“Abiomed is committed to investing in innovative research to improve patient outcomes. We believe that reducing heart muscle injury is the key to recovering hearts, avoiding heart failure, improving patient quality of life and reducing health care costs,” CEO Minogue said in a prepared release.

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MassDevice.com +5 | The top 5 medtech stories for October 27, 2016

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Titan Medical adds $900k to $8m overnight offering

MassDevice.com news

Titan Medical said today that it brought in another $909,000 after the underwriters of an overnight offering picked up their over-allotment option.

Toronto-based Titan said it sold some 2 million shares at about 44.8¢ (C60¢) apiece, adding $909,000 (C$1.2 million) to the $7.7 million (C$10.25 million) it raised in the initial offering last month. Read more


4. Nihon Kohden wins $35m patient monitoring deal with US Defense Dept.

MassDevice.com news

The American division of Japan’s Nihon Kohden won a Pentagon contract worth more than $35.3 million, the U.S. Defense Dept. said yesterday.

The 1-year deal, which has 8 1-year extension options, calls for Irvine, Calif.-based Nihon Kohden America to supply the U.S. Air Force, Army, Navy, Marine Corps and federal civilian agencies with its patient monitoring equipment, according to a press release. Read more


3. St. Jude Medical’s shareholders OK $25B Abbott buyout

MassDevice.com news

St. Jude Medical said yesterday that its shareholders voted to approve its pending, $25 billion buyout by Abbott.

Preliminary results showed that about 99% of shareholders at the annual meeting voted to OK the deal, representing about 74% of all outstanding stock. Little Canada, Minn.-based St. Jude said it plans to release the final vote results in an SEC filing later this week. Read more


2. Zimmer Biomet picks up tele-rehab provider RespondWell

MassDevice.com news

Zimmer Biomet said today that it paid an unspecified amount for tele-rehabilitation provider RespondWell, which it plans to fold into its recently launched Signature Solutions business.

RespondWell provides personalized, clinician-supervised post-surgical physical therapy programs for patients to complete at home after joint replacement surgery. Read more


1. Abbott slapped with $4m loss in age discrimination suit

MassDevice.com news

A jury in Puerto Rico yesterday slapped Abbott with a $4 million loss in an age discrimination lawsuit filed by a former employee there.

Luz González Bermúdez sued Abbott and manager Kim Pérez in August 2014, alleging age discrimination after her transfer from Abbott’s Health Care Professional unit to its marketing group under Pérez. Read more

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