Federal Jury Returns $247 Million Verdict in Defective Hip Implants Case

DALLASNov. 16, 2017 /PRNewswire/ — A federal court jury in Texas returned a $247 million verdict on behalf of six people who suffered serious medical complications caused by the defective metal-on-metal hip implants made by Johnson & Johnson (NYSE: JNJ) and its subsidiary DePuy Orthopaedics Inc.

The one-man, seven-woman jury deliberated for 14 hours before reaching its verdict, which includes more than $78 million in compensatory damages for the six plaintiffs and more than $168 million in punitive damages assessed against Johnson & Johnson and DePuy.

The verdict, delivered November 16, 2017, follows claims filed by New York residents Ramon AliceaUriel BarzelKaren KirschnerHazel MiuraMichael Stevens, and Eugene Stevens who received DePuy’s Pinnacle Acetabular Cup System hip implant. The plaintiffs alleged that the devices had unreasonably high failure rates resulting in severe pain and inflammation, bone erosion, tissue loss and other problems. The victims further claimed that DePuy officials knew about the dangers of the Pinnacle hip implants but failed to warn doctors or patients.

“We thank this jury for sending a very strong message about the responsibility the defendants have to take care of their consumers,” said lead attorney Mark Lanier of The Lanier Law Firm in Houston. “Unfortunately, it took the defendants putting the plaintiffs through burdensome litigation before justice could be served. The companies should have done the right thing when these serious medical concerns became known many years ago.”

The trial was the fourth “bellwether” in the multidistrict litigation (MDL) consolidating more than 9,000 similar lawsuits nationwide. Bellwether trials are set to establish evidence and evaluate witness testimony that is representative of the issues involved in mass litigation. Two previous trials involving plaintiffs from California and Texas resulted in verdicts of $502 million and $1.04 billion.

The case, presided over by U.S. District Court Judge Ed Kinkeade of the Northern District of Texas, is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, No. 3:11-md-02244.

With offices in HoustonNew York and Los Angeles, The Lanier Law Firm is committed to addressing client concerns with effective and innovative solutions in courtrooms across the country. The firm is composed of outstanding trial attorneys with decades of experience handling cases involving pharmaceutical liability, asbestos exposure, commercial litigation, product liability, maritime law, and sports and entertainment law. Visit http://www.lanierlawfirm.com.

Contact:
J.D. Cargill
The Lanier Law Firm
713-659-5200 or jdc@lanierlawfirm.com

 

SOURCE The Lanier Law Firm

Related Links

http://www.lanierlawfirm.com

MedShape Announces FDA Clearance for the DynaNail® XL

ATLANTANov. 14, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DynaNail® XL TTC Fusion System. The DynaNail XL is available in 260mm and 300mm lengths, thus expanding the product’s use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM) nail. The DynaNail XL will be launched in early 2018.

Indicated for tibiotalocalcaneal (TTC) fusion surgery, the DynaNail XL was developed in response to surgeon demand for an IM nail that better accommodates longer patient tibial anatomies or when tibial fractures are present. Its longer length in combination with DynaNail’s pseudoelastic NiTiNOL Element could help reduce stress risers in the bone, consequently lowering the chance for tibial fractures.1 DynaNail XL features a similar design as the original 220 mm version but also has a proximal taper for easy insertion through the tibial isthmus and an extra proximal screw hole for an optional cortical screw for additional stability.

Clinically introduced in 2012, the DynaNail is the first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL to provide the compression performance of an external frame inside an IM nail design. Compression has shown to be important not only in keeping the bones in close apposition but also in providing the physiological stresses needed to promote bone healing.  Like the original 220mm version, the DynaNail XL features an internal NiTiNOL Compressive Element that maintains post-operative compression for up to 6 mm of bone resorption and settling. The DynaNail Compressive Element also allows for effective load sharing across the bone due to its axial compliance during weight-bearing.2 To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic.3,4,5

The FDA clearance of the DynaNail XL closes out a year noted by several updates to the DynaNail product line. In June, the DynaFrame™ Carbon-Fiber (CF) Deployment System was launched, providing surgeons with a simple, robust method to insert the DynaNail and activate the NiTiNOL element during surgery. This was followed by the release of new instrument sets to accommodate the increased demand. Finally, with the DynaNail XL, MedShape also gained clearance to offer a new alternate surgical technique that allows for a more streamlined approach and the option for automatic dynamization once the NiTiNOL Element has fully recovered.

“The recent additions to the DynaNail portfolio demonstrate our continued commitment toward improving upon the success of the company’s flagship product,” said Kurt Jacobus, MedShape CEO. “We have been pleased with the growing adoption of this unique technology by both orthopaedic surgeons and podiatrists and anticipate continued growth with these new offerings.”

About MedShape, Inc.

MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions for foot and ankle and trauma surgeons that use its patented advanced material technologies. For more information, visit: www.medshape.com.

1Catanzariti, A. R., DPM, & Mendicino, R. W., DPM. (2009). Intramedullary Nail Fixation for Reconstruction of the Hindfoot and Ankle in Charcot Neuroarthropathy. In Surgical Reconstruction of the Diabetic Foot and Ankle (pp. 241-254). PhiladelphiaWolters Kluwer.

2Anderson RT, Pacaccio DJ, Yakacki CM, Carpenter RD. Finite element analysis of a pseudoelastic compression-generating intramedullary ankle arthrodesis nail. J Mech Beh Biomed Mat, 2016; 62: 83-92.

3Kreulen C, Lian E, Giza E. Technique for Use of Trabecular Metal Spacers in Tibiotalocalcaneal Arthrodesis with Large Bony Defects. Foot Ankle Int, 2017; 38(1): 96-106.

4Latt LD, Dupont KM, Smith KE. Revision Tibiotalocalcaneal Arthrodesis with a Pseudoelastic Intramedullary Nail – A Case Study. Foot Ankle Spec; 2017; 10(1): 75-81.

5Hsu AR, Ellington JK, Adams SB, Jr. Tibiotalocalcaneal Arthrodesis Using a NiTiNOL Intramedullary Hindfoot Nail. Foot Ankle Spec 2015; 8(5): 389-96.

DynaNail and DynaFrame are a registered trademark and trademark of MedShape, Inc, respectively.

Media Contact:
Jenn Pratt
Carabiner Communications
678.313.3438
jpratt@carabinercomms.com

Company Contact:
Kathryn Smith, Ph.D.
678.235.3304
Kathryn.smith@medshape.com

 

SOURCE MedShape, Inc.

Related Links

http://www.medshape.com

IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread Fibula Pin System.

The IntraFuse FlexThread Fibula Pin System provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures.  The simple and elegant design is easy to insert and cost competitive with today’s standard-of-care internal fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod.  Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal.  With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period. Additionally, the FlexThread Fibula Pin is compatible with either screw or flexible fixation of the syndesmosis joint as needed.

To accommodate the anatomic size range of fibulas, the FlexThread Fibula Pin is available in three different screw diameters, each with two length options.  Using routine intramedullary and screw fixation techniques, bone preparation is a simple, three step sequence:  place guide wire, ream, tap.   Optional fracture site compression is achieved concurrent with insertion of the implant, and delivery of cross fixation screws is facilitated by a guide that connects directly to the implant inserter.

The FlexThread Fibula Pin provides anatomic, intramedullary fixation that may have potential clinical advantages over fibula plating systems, including: reduced risk of hardware related pain, reduced rate of hardware removal, less risk of wound complications, infection and other morbidities due to a less invasive procedure, and less disruption of the periosteum which facilitates faster healing.

“Intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities,” states Wade Fallin, CEO of IntraFuse.  Fallin continues, “FlexThread™ is a platform technology that can address the unique requirements for intramedullary fixation of small bone fractures where off-axis entry into the bone canal is required, or where the bone is curved.  Now cleared for both clavicle and fibula fractures, the FlexThread™ technology is in further development for additional indications.”

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair System

LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative SyndesMetricsÔ Syndesmosis Repair System.

The Mortise Medical SyndesMetricsÔ Syndesmosis Repair System was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability.  Anatomic reduction is achieved using the SyndesMetricsÔ Reduction Clamp, which features: anatomic referencing clamp points; precision, surgeon controlled, calibrated clamping force; and an integrated drill guide to prepare the bone for the SyndesMetricsÔ  implant system.  Both the SyndesMetricsÔ Reduction Clamp and implant system are compatible with distal fibula plating systems.  Also, the SyndesMetricsÔ implant system features minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.

Based on biomechanical testing on matched pair human cadaveric ankle specimens at the University of Iowa, the SyndesMetricsÔ implant system was found to more closely reproduce normal physiological ankle motion when compared to a 4.5mm cortical screw or a suture button construct.1  Additionally, mechanical testing conducted by a third party medical device testing company demonstrated that SyndesMetricsÔ repair constructs had higher static strength and higher fatigue strength than 3.5mm cortical screw or suture button repair constructs.2

“Surgeons will find this innovative system more intuitive to use and more reproducible for positioning and tensioning the distal tibiofibular syndesmosis than anything we now have available,” states Dr. Charles L. Saltzman, Professor and Chairman of Orthopaedics at the University of Utah and immediate past President of the International Federation of Foot and Ankle Societies.

Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.

1 Goetz JE, et al., Annual Meeting of the American Society of Biomechanics, 2017

2 Data on file

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

Trump picks Alex Azar to lead the Health and Human Services Department

 / November 13, 2017

President Trump has selected Alex Azar, a former pharmaceutical executive and a top health official during the George W. Bush administration, to lead the Health and Human Services Department.

The decision to enlist the 50-year-old Azar — who served as president of Lilly USA, the biggest affiliate of Eli Lilly and Co., before stepping down in January to work as a health-care consultant — represents a pragmatic pick. An establishment figure with a reputation as a conservative thinker and methodical lawyer, Azar would be expected to use his experience as HHS general counsel and deputy secretary to pursue Trump’s goals through executive action.

In announcing the nomination Monday morning, Trump tweeted that Azar “will be a star for better healthcare and lower drug prices!” He has a close rapport with the department’s top political appointees as well as Vice President Pence.

Azar has been highly critical of the Affordable Care Act, telling Fox Business in May that the law was “certainly circling the drain” and saying in a speech two months ago that many of its problems “were entirely predictable as a matter of economic and individual behavior.”

In a June interview on Bloomberg Television, Azar made it clear he thought the administration could shift the ACA in a more conservative direction even if congressional Republicans failed to repeal much of it. “I’m not one to say many good things about Obamacare, but one of the nice things in it is it does give tremendous amount of authority to the secretary of HHS,” he said.

He also supports converting Medicaid from an entitlement program covering everyone who is eligible into block grants, a long-standing GOP goal that has sparked opposition from Democrats as well as some centrist Republicans. He has opposed expanding the program under the ACA to people with slightly higher incomes.

The nominee boasts sterling conservative credentials, clerking for the late Supreme Court Justice Antonin Scalia before working under special counsel Kenneth Starr to investigate Bill Clinton’s failed Whitewater real estate investments. Still, administration officials think he could work more deftly with competing health-care interests and politicians than his predecessor, Tom Price.

 

READ THE REST HERE

DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

BALTIMORENov. 8, 2017 /PRNewswire/ — DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The Hintermann Series H2™ is a semi-constrained, total ankle replacement prosthesis developed by Prof. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The Hintermann Series H2™ Total Ankle Replacement System is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis), primary arthritis (e.g., degenerative disease), and secondary arthritis (e.g., post-traumatic, avascular necrosis). The Hintermann Series H2™ is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided that sufficient bone stock is present. The Intellectual Property of the Hintermann Series H2™ is protected by numerous patents with additional patents pending.

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters located in Raleigh, NC, and through specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2™ Total Ankle Replacement System. I want to thank our employees, M Squared Associates and other advisors, and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”

DTM continues to market and distribute its Hintermann Series H3™ mobile-bearing Total Ankle Replacement System outside of the United States in over 30 countries. The Hintermann Series H3™ is a substantiated leader for the international ankle replacement market with more than 17 years of proven clinical efficacy outside of the United States.

Prof. Beat Hintermann, developer of the Hintermann Series™ Total Ankle Systems, stated, “I am looking forward to adding the H2 as a semi-constrained option for my patients alongside the H3* mobile-bearing prosthesis. With the addition of the new H2 prosthesis, I will be able to expand my indications and patient selection for total ankle replacements.”

DTM anticipates a limited release of the Hintermann Series H2™ in early December 2017 outside the United States, as it has already received the CE mark for the device, along with registrations in many additional key markets. DTM will be focusing on training, sales, and distribution of the Hintermann Series H2™ in the United States markets and in markets outside the United States through DT MedTech International Limited (DTMI), DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.

For additional DTM information inside the United States please email info@DTMedTech.com or call Ms. Jeannie Sardaat 410-427-0003; outside the United States, please email dtmedtech@healthlinkeurope.com or call +31 73 303 2537.

About DT MedTech, LLC

DT MedTech, LLC, is the parent company of DTMI and European Foot Platform, S.A.R.L. and DTM and its subsidiary companies maintain offices in Baltimore, MarylandDublin, IrelandSaint-LouisFrance; and Liestal, Switzerland. As a member of the Data Trace family of businesses, leaders in scientific and medical publishing, marketing, surgical training, clinical trial management, medical malpractice insurance, and information services for more than 30 years, DTM provides innovative surgical solutions for lower extremity surgeons with state-of-the-art devices such as The Hintermann Series™ Total Ankle Replacement Systems.*

*Hintermann Series H3™ is not available for sale within the United States and its territories.

SOURCE DT MedTech, LLC

Related Links

http://www.dtmedtech.com

Patients sue B. Braun alleging defect in replacement knees

By Peter Hall of The Morning Call / November 7, 2017

Medical device maker B. Braun concealed from regulators problems with its line of ceramic-coated artificial knees and promoted the products to surgeons despite knowing they were prone to fail, a lawsuit filed in a California court alleges.

The Bethlehem-based company’s Aesculap Implant Systems subsidiary marketed the “advanced surface” ceramic coated knees as superior to standard bare metal implants, claiming they would last longer, the lawsuit says. But the ceramic joints were defective, the suit alleges, because they didn’t adhere properly to cement used to bond them with the patients’ bones.

As a result, the 25 knee replacement patients who are suing B. Braun and Aesculap in a California court were or will be required to undergo additional surgeries to correct problems with the joints or implant different devices, the suit says.

A spokesman for B. Braun, a German company with U.S. headquarters in Bethlehem, did not respond to messages Tuesday.

The lawsuit was filed last month in Los Angeles Superior Court by attorneys Christopher K. Johnston of Guaynabo, Puerto Rico, and Anthony Buzbee of Houston on behalf of the patients, who are from Louisiana, Florida and 10 other states.

According to the lawsuit, Aesculap sought and received permission from the U.S. Food and Drug Administration to sell its advanced surface replacement knees by demonstrating that the devices were as safe and effective as devices that had already been approved. The process is less rigorous than the FDA’s standard medical device approval process, the suit says.

 

READ THE REST HERE

 

Amedica Submits 510(k) Application to FDA for Valeo C+CSC with Lumen

SALT LAKE CITY, Nov. 06, 2017 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, announced that the company made a 510(k) submission to the U.S Food and Drug Administration for its  Valeo C+CSC with Lumen spinal implant.

The Valeo C+CSC with Lumen is a modified CSC (cancellous structured ceramic) that is similar to Amedica’s commercially available Valeo C and Valeo C+ CSC (cleared in Europe only) cervical implants. This device increases implant surface area and plays an active role in the spinal fusion process while maintaining the other benefits silicon nitride brings to patients and physicians.

“The Valeo C+CSC with Lumen submission is a key step in introducing our proprietary porous silicon nitride technology into the US market. We look forward to working with the FDA on this important company milestone,” said Dr. Sonny Bal, Amedica CEO

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on September 20, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

LOGAN, UtahNov. 1, 2017 /PRNewswire/ — IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread™ Fibula Pin System.

The IntraFuse FlexThread™ Fibula Pin System provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures.  The simple and elegant design is easy to insert and cost competitive with today’s standard-of-care internal fixation hardware. Incorporating IntraFuse’s proprietary FlexThread™technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod.  Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal.  With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period. Additionally, the FlexThread™ Fibula Pin is compatible with either screw or flexible fixation of the syndesmosis joint as needed.

To accommodate the anatomic size range of fibulas, the FlexThread™ Fibula Pin is available in three different screw diameters, each with two length options.  Using routine intramedullary and screw fixation techniques, bone preparation is a simple, three step sequence:  place guide wire, ream, tap.   Optional fracture site compression is achieved concurrent with insertion of the implant, and delivery of cross fixation screws is facilitated by a guide that connects directly to the implant inserter.

The FlexThread Fibula Pin provides anatomic, intramedullary fixation that may have potential clinical advantages over fibula plating systems, including: reduced risk of hardware related pain, reduced rate of hardware removal, less risk of wound complications, infection and other morbidities due to a less invasive procedure, and less disruption of the periosteum which facilitates faster healing.

“Intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities,” states Wade Fallin, CEO of IntraFuse.  Fallin continues, “FlexThread™ is a platform technology that can address the unique requirements for intramedullary fixation of small bone fractures where off-axis entry into the bone canal is required, or where the bone is curved.  Now cleared for both clavicle and fibula fractures, the FlexThread™ technology is in further development for additional indications.”

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin
CEO
182962@email4pr.com
www.surgicalfrontiers.com
800-230-3710

SOURCE IntraFuse

Related Links

http://www.surgicalfrontiers.com

Intellijoint Surgical Inc. Receives FDA Clearance for Revision THA with intellijoint HIP®

WATERLOO, ONNov. 1, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received FDA Clearance for revision Total Hip Arthroplasty (THA) with its intellijoint HIP® System. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for THA. Requiring no pre-operative or intra-operative imaging, intellijoint HIP can be used with any implant manufacturer, and for any primary or revision THA.

The revision indication provides surgeons with the ability to evaluate existing THA components to inform intra-operative decision making. The possibility to leave existing components in place can greatly reduce risk to the patient and can contain cost for the hospital.  Other image based technologies are not suitable for revision THA as existing components create distortion to pre-operative images, making them unusable for critical patient registration.

“intellijoint HIP for revision gives me accurate positioning information about the existing cup. I can then determine which acetabular components need to be removed due to the component being malpositioned,” explained said Dr. Wayne Paprosky, Midwest Orthopaedics at Rush and a member of Intellijoint’s scientific medical advisory board.  “I can document the position to defend why I removed or retained the component. When I am able to leave the cup in place, particularly in high risk patients, the risk of complication is greatly reduced and the procedure is significantly shortened.”

intellijoint HIP is available for Anterior, Posterior and Lateral approaches and can be used on primary and now revision THA. This milestone supports Intellijoint Surgical’s mission of making intellijoint HIP accessible to every surgeon and every patient.

“Our core technology is well suited for revision surgery as it provides accurate intra-operative information without relying on pre-operative x-rays or imaging of any kind,” added Intellijoint Surgical CEO Armen Bakirtzian. “Image-based robotics and navigation systems rely heavily on pre-operative imaging, which could result in significant inaccuracies due to image distortion by metal from the existing components”.

Visit Intellijoint Surgical at the upcoming American Association of Hip and Knee Surgeons (AAHKS) annual meeting (booth 100) in Dallas, Texas from November 3rd to 4th to learn about the cutting-edge technology behind intellijoint HIP.

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

SOURCE Intellijoint Surgical Inc.

Related Links

https://www.intellijointsurgical.com/