October 2nd

ConforMIS releases its improved iTotal G2.

ConforMIS is fully aware that the first generation of a product isn’t perfect. Last year it released its iTotal TKR in a limited capacity. During that time, the company gathered surgeon feedback and used the data to further tweak the device. "Our experience has been that to have a product that is appealing to a broad range of surgeons, you need to make sure that the you give them the ability to perform surgeries in the way they prefer," said Jong. "The limited release allows us to get that feedback in a controlled way, using a broader group of surgeons than the developer surgeons. The changes incorporated into the G2 launch reflect that feedback, gathered from surgeons with different training and different approaches."

The result is the iTotal G2, which has now been launched into broad commercial release. Improvements to the system include developing an implant that addresses a broader range of anatomies—obesity is a growing problem in the United States, and some patients were too large for ConforMIS’s first generation iTotal device.

"The G2 system provides surgeons with additional information in their surgical planning images, incorporates implant modifications to allow them to use the iTotal on a broader range of their patients, and has instrument changes that allow better visualization, fewer steps to the surgical technique, and more options for the surgeon," says Jong. "Each change is quite small but together, they make for a comprehensive update to the system."
 

What's the ideal TKR from the orthopaedic surgeon perspective? Jong Lee says surgeons want a TKR that:

  1. Helps to close the gap on patient dissatisfaction.
  2. Avoids residual pain.
  3. Doesn't limit patient function.
During the limited release stage, ConforMIS selected a broad range of surgeons. “Designer surgeons can make anything work,” Jong Lee, senior vice president of marketing and business strategy at ConforMIS, told OrthoTec at the AdvaMed 2012 conference. During the limited release, the iTotal was used by academic and community-based surgeons, as well as those who practice in a high-volume or minimally-invasive capacity. Having this diverse group enabled the company to get the most challenging feedback. “[They] influenced the direction on the final release,” Jong said. “We’re confident this system is a broadly usable system that can be used in everyone’s [any surgeon’s] hands.”
 
As for surgeon adoption, Jong said that while nearly 25% of orthopaedic surgeons probably won’t adopt the iTotal G2 (at least not for a long time), about 25% is ConforMIS’s target group, and the remaining 50% could swing either way. The company is relying on the iTotal G2 to carry the company to the next level. “Total knee replacements are the bread and butter for surgeons who are doing knees,” said Jong. “[The G2] will be the predominant driver of our life as a company for the next two years. We think we can continue on a [strong] growth rate for a long time.” Jong firmly believes that ConforMIS is the fastest growing orthopaedic company. Although he is mum about other avenues that the company is pursuing, he confirmed that ConforMIS is indeed exploring using its platform outside of the knee area, but he still wouldn’t say when.

 

Maria Fontanazza is managing editor of UBM Canon. Follow her on Twitter: @mariafontanazza.

Maria Fontanazza
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October 1st

Prompted by some mainstream media finger pointing, UBM Canon's editor-at-large Brian Buntz takes a look at some of the numbers behind the controversy surrounding the Synthes Norian XR product. Buntz reports:

  • 94.17% of adverse reports involving calcium compound bone void fillers were filed by manufacturers compared Vs. 97% across the broader category of bone cements and fillers.
  • In 2011, Synthes reported the most adverse events of all the makers of calcium compound bone void fillers, an increase from 0 in 2008 to 22 in 2011.

Get more details about the Synthes Norian debacle from MPMN.

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"We suspect it will help grow cells in the $1.5 billion interbody market segment in the US. We believe that because there’s a need this segment right now for improved technology."
--Amedica president and CEO Eric Olsen on the expanded claims of the company's interbody devices.

PEEK has been a successful alternative to metals in the spine segment for several years. And while new uses continue to emerge, options beyond PEEK are also gaining recognition. Most recently, the expanded claims for Amedica Corp.’s (Salt Lake City) interbody fusion devices are confirmation that other enhanced materials exist as a viable option for spine surgeons. Amedica’s products use silicon nitride (Si3N4), a biomaterial that helps reduce the risk of infection, which can be a pesky problem for some patients. “I speak to a lot of patients who have had infected implants,” says Thomas Webster, PhD, professor and chair of the department of chemical engineering at Northeastern University. “[They tell me about] the pain they go through to have that implant removed and have another inserted—[and] many times there are cases of implants getting infected time and time again, for the same patient.”

In vivo and in vitro studies (published in Acta Biomaterialia and the International Journal of Nanomedicine) reveal that silicon nitride improves osteointegration and possesses “superior” antiinfection abilities compared to PEEK and titanium.
 
Webster, the lead study investigator, says the differences between silicon nitride and PEEK and titanium are “amazing”. In the in vivo studies, the investigators put bacteria on the samples, which were implanted into rodent skulls. After 90 days, no bone grew on PEEK and very little grew on titanium, and the bacteria were overtaking the implants on both. However, the silicon nitride Amedica sample showed a significant amount of bone growth after 90 days while also stopping bacteria growth.
 

"Sometimes I hear from patients that they’ll never be the same after having an infected implant. It’s speaks to decreasing significantly the number of revision surgeries due to infection."
--Thomas Webster on the need for implants that have anti-infective properties.

“For someone who has been in this field for about 15 years, what makes this amazing to me is that we didn’t use antibiotics,” says Webster. “We didn’t add a current antibiotic that an orthopedic surgeon would add if they saw signs of infection. This was just the raw chemistry, the raw surface properties of silicon nitride that made it a much better bone-growing material and antibacterial material than something like PEEK and titanium.” Silicon nitride is also semi-radiolucent, which helps with both accurate interoperative implant placement and tracking the implant postop.
 
Silicon nitride is used in all of Amedica’s devices. Its first device was implanted in 2008, and the company has seen 8500 implantations since. “We’re looking to dramatically expand the sales of our interbody devices and to do that very quickly,” says Eric Olsen, president and CEO. “Our sense is that there’s no other material out there that has these types of claims that are based on published data in peer-reviewed journals.”
 
Amedica also has a CE mark for cancellous-structured ceramic (CSC), which is made from silicon nitride. The CSC is used in an interbody device that replicates hard cortical bone on the outside while the CSC mimics cancellous bone in the center. Its porous structure allows bone to grow into the material, facilitating more effective osteointegration. Olsen says the company is in the process of enrolling patients in a couple of clinical studies to determine the long-term benefits of the material.

Maria Fontanazza is managing editor at UBM Canon. Follow her on Twitter @mariafontanazza.

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September 11th

The country’s market is a relevant competitor to the United States and Europe.

Boasting one of the world’s fastest growing economies, Brazil is receiving worldwide commercial attention. Its medical device industry does not escape this newfound focus and is experiencing growth in several of its sectors, one of which is the orthopaedic trauma device market. Growing at twice the rate of the European market, and at a rate comparable to that in the United States, the Brazilian orthopaedic trauma devices market is steadily expanding due to the country’s demographics, health insurance policies, and laws. Instituted after the 1988 constitution, Brazil’s Unified Health System (Sistema Único de Saúde (SUS)) governs more than half of the trauma products used in the country, but corresponds to less than a third of total market revenues. This structure explains why Synthes continues to be a leading competitor in the Brazilian trauma device market even though it does not participate in the public sector. The disparity between SUS and private pricing has lead to a gradual decline in average selling prices, where SUS pricing remains stable while private pricing declines due to increasing competition and pressure. However, despite declining prices, the market will continue to thrive due to other factors, such as Brazil’s rapidly growing economy, its aging population, and an increase in motor accidents.

More Traffic Accidents = More Trauma-related Injuries

Orthopaedic emergency centers in Brazil often see a large influx of patients suffering from injuries related to traffic accidents, the highest incidences involving motorcyclists. Traffic accidents represent the main cause of hospitalization through Brazil’s SUS. According to the Brazilian Ministry of Health, traffic accidents cost more than R$100 million per year; this is more than 30% of the budget that the Ministry allocates to accidents derived from external causes. Traffic accidents are the greatest cause of multiple fracture injuries, which require immediate emergency assistance and often, highly specialized treatment.
 
The unit sales growth of large plate and screws, and hip intramedullary nails in Brazil (2011). Source: iData Research.
The highest incidence of these trauma fractures happens to the inferior members of the body, followed by the superior members, head, and spine, according to studies conducted in Brazilian states. This might explain the high growth rate of proximal femoral intramedulary nail usage as well as plate and screw systems that tend to the tibia and femur. In 2011, the femoral and tibial intramedullary nail unit sales, as well as the large fracture plate and screws saw an increase of more than 8% over the previous year. In addition, the hip intramedullary nail market experienced double digit growth. It is predicted that as the population in metropolitan centers increases and more people are able to afford motorcycles, so will the incidences of trauma injuries.

Brazil’s Public Health System Stunts Market Growth

More than 70% of Brazilians today rely on the SUS.  The system’s mission is to make healthcare available to everyone in the country irrespective of their class or social status. Out of all the hospitals in Brazil, nearly 75% operate under the SUS. It is estimated that 65% of the total trauma market is controlled by manufacturers selling under the SUS standard pricing. The prices of procedures and equipment set by the SUS are used as a reference when selling to public hospitals, laboratories, blood banks, and other sites, and suffer little variation with time. This standardized pricing scheme limits the market, because distributors and product manufacturers cannot increase their pricing above SUS standards when selling to major hospitals and doctors. Moreover, as the quality of the equipment produced by the companies working under the SUS increases, they are bound to compete with the products marketed in the private sector and will inevitably deteriorate the pricing of those products.
 

U.S. Market Drivers:
Where Bone Graft Substitutes Stand 

The market has seen tremendous growth in the past decade, despite the growing competition for market share.

Synthes Leads Private Trauma Market

In Brazil, there is a large price discrepancy between manufacturers that sell their products through the SUS and the ones insured through private insurance companies. For this reason, it is worth dividing the Brazilian market into public and private sectors. Synthes is the leader in the private market, holding more than 25% of total revenues. The company’s position can be attributed to its lead in both the internal and external fixation market segments within the private sector.
 
Growth in Synthes’s trauma division is attributed to the introduction of new products in the latter part of 2011. In the fourth quarter, the company launched its Dynamic Locking Screw, which features a pin-sleeve design that enables dynamic motion and locking technology. The technology improves bone healing and is ideal for use in fracture bridging. Additionally, in April 2012 the EU approved of DePuy’s $23.1 billion proposed acquisition of Synthes, including its trauma business. Although Synthes was a market leader in 2011, its presence will be merged with DePuy in 2012 (the acquisition was finalized at the end of June).
 
In 2011, the Brazilian company Hexagon was the number one competitor in the public market and the third-leading competitor in the total Brazilian orthopaedic trauma market (public and private). Hexagon’s large share in the market can be linked to several factors. It carries most types of internal and external trauma devices and hasthe largest stock of raw material in Brazil. The company’s products are also available in all of the country’s major hospitals and trauma care centers. Manufacturing more than one million implants per year, Hexagon occupies the premium end of the market and has a strong sales force. The company has been growing steadily for more than 20 years and continues to solidify its presence in Brazil’s trauma device market.
 
The information contained in this article is taken from a detailed and comprehensive report published by iData Research entitled “Brazilian Market for Orthopedic Trauma Devices”. For more information about the report, contact iData Research at orthopedics@idataresearch.net.
 

More on Orthopaedic Device Markets

 

Kamran Zamanian, PhD, Lucie Semenec, and Olivia Fellows
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August 30th

Although recently dropped, the DOJ case exposes risks in the physician-manufacturer relationship.

Earlier this year the U.S. Department of Justice announced that it was dropping all criminal charges against former Stryker Biotech employees shortly after the start of what was expected to be a fiercely fought six-week trial. Just days earlier, the government had settled with Stryker Biotech for a single misdemeanor plea and a $15 million fine—a paltry sum compared to fines of several hundred million dollars and even billions of dollars that the federal government has secured in other drug and medical device cases. When the Stryker trial abruptly ended, it seemed that much of the entire medical device industry breathed a collective sigh of relief.

The Stryker Biotech case exposed certain potential vulnerabilities inherent in the relationships between medical device companies and physicians that should receive the industry’s full attention. The decision of the Boston U.S. Attorney’s Office to wrap up its case so early in the proceedings temporarily precluded any public airing of these issues.
 
Given broad public concerns about potential doctor-industry conflicts of interest and the quality and cost of healthcare, aggressive law enforcement, legislative action, and civil litigation against medical device firms are not going away any time soon. While working with policy makers, the medical device industry would help itself greatly by addressing some of the difficult questions posed by the Stryker case and other legal proceedings. Fundamentally, our legal system must balance the need to insulate physicians from undue industry influence with the fundamental role that industry-physician collaboration plays in research, innovation, and the safe and effective use of medical devices.

Read the full article, "Stryker Biotech Case Exposes Risks in Physician-Manufacturer Relationship," on MD+DI's site.

Robert L. Ullmann
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August 20th

The event is being held September 12-13 in Zurich.

OrthoTec Europe is less than a month away, but there's still time to register for the event in Zurich. In its third year, the conference and exhibition will feature some new elements, including the Investment Hub, which will give future innovators the chance to present their idea to a panel of experts. During the conference, speakers will discuss a range of technical and regulatory topics, including MDD changes, regulatory issues in China, and emerging markets. 

OrthoTec Europe, September 12-13, 2012

 

For more coverage of the event, visit MEDTEC Connection. Get instant updates by following @OrthoTecEurope and download the free mobile app!

 

The event's U.S. counterpart was held earlier this year in Warsaw, IN.

Maria Fontanazza
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July 23rd

Teleflex Inc. (Limerick, PA), a global provider of medical technology products, has announced that it has entered into a definitive agreement to sell its OEM orthopedics business to Tecomet for $45.2 million in cash. Financing for the transaction was arranged by Charlesbank Capital Partners, the majority owner of Tecomet. The Teleflex Medical OEM orthopedics business includes the Beere Medical and SMD brand product lines. Beere Medical offers one of the world's largest collections of custom surgical instruments used for orthopedic and spinal procedures. SMD is a market leader in micro-machined products ranging from simple components to complex devices. Core capabilities include implant systems (spinal, small bone, dental), mono- and poly-axial screws, flat or anatomic plates, straight or pre-bent rods, connectors, and implant insertion instruments. The OEM orthopedics business generated net revenues of approximately $36 million in 2011. Upon completion of the transaction, the Teleflex Medical OEM division will fully focus on expanding its Deknatel and TFX OEM brands, none of which are impacted by today's announcement. The OEM division holds global leadership positions in custom extrusion, catheters, medical devices, sutures, and performance fibers. 

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Company
Results
Growth
DePuy (Revenue—Worldwide)
$1.6 billion (Q2 2012)
 
      United States
$873 million
13.4%
       International
$755 million
8.0%
       DePuy notes: DePuy’s growth was boosted by sales from the company’s acquisition of Synthes.
Stryker (Sales)
$2.1 billion (Q2 2012)
3%
      Stryker notes: The company is still searching for a new CEO, and the board is reviewing internal and external candidates. It doesn’t expect to name a permanent CEO this year.      
Biomet  (Net Sales)
$739.5 million (Q4 2012)
5%
     United States
$439.5 million
7%
     Europe
$182.4 million
-8%
     International (Canada,   South America, Mexico, and the Pacific Rim)
$117.6 million
12%
     Biomet notes: Net sales for FY 2012 (ending May 31) $2,838.1 million, a 4% increase from $2,732.2 million for FY 2011.
Zimmer (Net Sales)
$1.125 billion (Q2 2012)
-1.1%
Exactech (Revenue)
$55.2 million (Q2 2012)
7%
     Knee implants
$21 million
1%
     Extremity implants
$12 million
24%
     Hip implants
$10.3 million
22%
     Biologic and Spine
$5.9 million
-1%
     Other products
$6 million
-14%
Smith & Nephew (Revenue)
$1.029 billion (Q2 2012)
2%
Wright Medical (Net Sales)
$123.3 million (Q2 2012)
-7%

 

Note: Data has been updated as of August 7, 2012.

Maria Fontanazza
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July 11th

 

Recent statistics have revealed that nearly three of ever four Americans over the age of 40 are experiencing knee pain. DJO Global, a provider of medical devices focused on musculoskeletal health, vascular health, and pain management, has released the OA Nano knee brace. The brace, designed for patients with mild-to-moderate osteoarthritis (OA) is an off-loading knee brace weighing 14.2 oz. The OA Nano achieves this light weight through being manufactured using nanoMAG TTMP, a new kind of metal that is as light as magnesium with the strength of aircraft-grade aluminum. OA Nano decreases pressure on the knee by offloading stress, allowing patients to enjoy physical activities pain free with greater stability than many other conservative care treatments. The OA Nano is made by the same team of engineers that developed braces for the NFL, NBA, and 21 of the top 25 NCAA college football teams. The knee brace is based on years of meticulous research and designed to optimize comfort, compliance, and efficacy through its light weight, flexibility, and low profile.  

 

Related:

U.S. Bracing and Supports Market to Exceed $2.48 Billion by 2018

NanoMAG Gets $100,000 for Resorbable Implant, Teams Up with Biomet

 
 

 

 

 

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July 10th

Resorbable materials have found a home in several key clinical areas within orthopaedics. Implants that integrate such materials offer benefits over traditional static metal implants, especially in function and strength, but their use requires careful consideration from manufacturers during every stage of product development.

Polymer Implant Complications
  • Material degrades too quickly, causing premature implant failure.
  • Toxic/acidic degradation
  • Material degrades too slowly, causing late-stage tissue reactions.
“It’s definitely a delicate balance,” said Elizabeth Perepezko, biomaterials research scientist of global fixation and antinfective technologies at Biomet Inc. Perepezko shared her expertise in working with resorbable materials at the 2012 OrthoTec conference.
 
First, let’s focus on the positives of polymeric implants. They provide temporary fixation and avoid stress shielding (by allowing the mechanical function to gradually transfer back to the intertissue). The end result is an implant that doesn’t need to be removed at a later point, which cuts down on surgeries.
 
Polymeric implants give surgeons more flexibility in the OR. Due to the glass transition temperature, polymeric implants can be easily manipulated using standard heating methods. “You can contour and modify it to the patient’s anatomy in the OR rather than having it premade and preplanned ahead of the surgery,” said Perepezko.
 
When designing implants, patient comfort is paramount, and polymeric implants offer permanent palpability. This characteristic is especially important in craniofacial applications. “[When] you can look at temperature changes with metallic [implants] in the jaw, you can have some discomfort in the patient in going from a warmer to colder rooms—they can have nerve discomfort,” said Perepezko.  
 
Resorbable Implants: A Look Inside
Now, here are the challenges. Polymers degrade by hydrolysis, and several factors affect degradation behavior. Modifying the composition of the polymer chemistry can influence the degradation rate, as can polymer processing, and where the implant is placed in the body. “There’s evidence to show that resorbable implants of the same composition, implanted above the neck and the lower extremities can have different degradation profiles,” said Perepezko. It’s important to consider what kind of circulation or metabolism is in the surrounding tissue. For example, bone and soft tissue have different water content. For patients with compromised circulation (such as diabetics), the use of resorbable implants can be risky. Manufacturers also need to think about whether the degradation of the implant will negatively affect the healing of surrounding tissue.
 
The manufacturing process itself presents problems to resorbable materials, because polymers are sensitive to heat, and thermal degradation is a challenge in standard polymer processing. “Controlling that and making sure that you’re not accelerating the degradation rate with processing is important,” said Perepezko. During polymer processing, injection molding and extrusion are aggressive methods that can have a high influence on the degradation properties of the material. To avoid shear damage, keep heat low.
 
Moisture levels must be carefully controlled during sterilization, packaging, and storage conditions. Gamma sterilization can accelerate the degradation profile, because the radiation can shorten the polymer chains. “You can try to build a cushion into your material so that whatever you’re losing in the gamma cycle is getting you to the point where you want to be, or you can use other methods like gas plasma or ethylene oxide,” said Perepezko. “But those two methods add moisture to the cycle, so now you have to consider what kind of moisture damage would affect your overall degradation profile.” Maintaining this balance can be one of the most crucial stages in the process.
 
Finally, manufacturers need to make sure the packaging and storage conditions are controlled, because the materials aren’t inherently stable. Being able to control moisture long-term is critical.

 

Maria Fontanazza is managing editor at UBM Canon. Follow her on Twitter: @MariaFontanazza.

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