30 Dec

FDA Issues List Of Priority Device Guidances For 2017

By Jof Enriquez - December 29, 2016 The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114). CDRH provides three lists: (1) a list of guidance documents that the Agency fully intends to publish (the "A-list"); (2) a list of guidance documents that the Agency intends to publish as resources permit (the "B-list"); and (3) a list of final guidance documents issued in 2007, 1997, 1987, and 1977 subject to focused retrospective review, as well as possible revision or withdrawal. Among the A-list are final guidance documents on medical device cybersecurity, next-generation sequencing-based diagnostic devices, and the use of real-world evidence (RWE) to aid regulatory decision-making. Cybersecurity and RWE also are included in CDRH’s top ten science priorities for 2017, announced in September. Included in the B-list are final guidance documents on unique device identification (UDI) and investigational device exemption (IDE) categories to support CMS coverage decisions. Also included is the draft guidance on electromagnetic compatibility of electrically powered medical devices, developed with the help of early stakeholder input. CDRH says it issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). Several guidance documents that were not published in FY 2016, but were deemed high priority through stakeholder feedback, are now on the annual agenda for FY 2017, according to RAPS. FDA says in a notice in the Federal Register that it welcomes comments on any or all of the guidance documents on the FY 2017 lists, allowing CDRH to better prioritize and more efficiently draft or finalize guidances, and to delete guidance documents that no longer represent the Agency's interpretation, thinking, or policy on a regulatory issue.   READ THE REST HERE

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30 Dec

PATIENT-SPECIFIC PLANNING FOR SHOULDER REPLACEMENT

Elizabeth Hofheinz, M.P.H., M.Ed. • Tue, December 27th, 2016

For many years the standard in training airline pilots has been pre-flight simulators. This helps them become more skilled at flying the actual plane. This is a comfortable thought isn’t it? Exactly! Well, recent developments in shoulder replacement surgery allow surgeons to simulate surgery and this benefits not only the patient, but also the hospital. Jon J.P. Warner, M.D. is chief of the Massachusetts General Hospital Shoulder Service and co-Director of the Boston Shoulder Institute. He and his colleagues are bringing clarity to the operating room via patient-specific planning for shoulder replacement.

Dr. Warner told OTW, “Joint replacement is expensive and the results are unpredictable; and unlike total hip and knee surgery, most orthopedic surgeons have limited experience with shoulder replacement surgery. Since shoulder replacement surgery is performed at a volume of <15% hip or knee replacement surgery, 90% of all shoulder replacements in the U.S. are performed by surgeons who do less than 5 procedures each year. Thus these surgeons may not have enough experience to avoid some common problems. These problems may include incorrect size selection and inaccurate placement of the shoulder replacement components.” “For shoulder replacement you must select a size that matches the patient’s anatomy, meaning that you have to have a full complement of instruments and implants on hand. To do a single operation the device manufacturer must deliver roughly $75,000 in inventory of instruments and implants; and if the surgeon opens a tray and doesn’t use it then it’s $100 to sterilize it. This economic reality challenges both the hospital and the company to provide cost-effective care.”   READ THE REST HERE

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30 Dec

Legislation Streamlines FDA Approval Process for Medical Device Industry

BY MAURY THOMPSON, THE POST-STAR, GLENS FALLS, N.Y. / DECEMBER 28, 2016
(TNS) — The federal Food and Drug Administration has required medical companies testing new products to get permission from multiple separate regional FDA review boards across the country wherever test subjects live. Legislation that President Barack Obama signed earlier this month will allow medical device companies the option of reporting to one centralized FDA review board, saving the companies time and expenses involved with the previous duplicative process. "Particularly for many of our start-up or smaller companies, a provision like that is really a beautiful regulatory efficiency proposal that doesn't do anything to change the importance or the soundness of the clinical trial," said JC Scott, chief advocacy officer for AdvaMed, a medical device industry trade organization. The provision is an example of myriad regulatory reforms of significance to the medical device industry in the 21st Century Cures Act, which Obama signed Dec. 13. The comprehensive legislation streamlines the regulatory process for pharmaceutical and medical device companies, sets medical research policy, and provides federal funding for medical research, including $1.8 billion in new funding for cancer research. "This critical legislation invests more in science and research, removes barriers that stand in the way of modern treatments, and advances personal medicine to ensure that patients can be treated based on their unique characteristics," said U.S. Rep. Elise Stefanik, R-Willsboro, in a news release.   READ THE REST HERE

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30 Dec

NuVasive to Resume XLIF Procedures in Japan in First Quarter 2017

SAN DIEGO, CA--(Marketwired - December 29, 2016) - NuVasive, Inc. (NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it received approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW).

Recent guidance from the MHLW requires dilators and associated components used in lateral access spine surgical procedures to be classified in Japan as Class III medical devices. NuVasive's dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in August 2011 with additional sizes approved in January 2014. As previously disclosed, NuVasive submitted its dilator and associated components for reclassification as Class III medical devices, and surgeons had temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.

With this approval from the MHLW, XLIF procedures in Japan will resume in the first quarter of 2017. In connection with the MHLW approval, NuVasive has agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.

"We've worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan," said Jason Hannon, NuVasive's president and chief operating officer. "Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013. As the industry leader in lateral procedures, we take our leadership responsibility seriously and have worked diligently with the MHLW to make XLIF available in Japan again. We thank the MHLW and our surgeon partners in Japan for supporting our efforts in keeping industry-leading innovation available to patients in need."

XLIF is a minimally invasive surgical (MIS) procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. There are over 350 peer-reviewed global journal articles reporting on the XLIF procedure over the last 11 years, which detail the positive outcomes and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.

The Company intends to provide preliminary guidance for 2017 revenue on January 9, 2017 at the J.P. Morgan Healthcare Conference.

About NuVasive

NuVasive, Inc. (NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive's highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA™ platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

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30 Dec

Legislation Streamlines FDA Approval Process for Medical Device Industry

Maury Thompson, The Post-Star, Glen Galls, N.Y - December 29, 2016 (TNS) — The federal Food and Drug Administration has required medical companies testing new products to get permission from multiple separate regional FDA review boards across the country wherever test subjects live. Legislation that President Barack Obama signed earlier this month will allow medical device companies the option of reporting to one centralized FDA review board, saving the companies time and expenses involved with the previous duplicative process. “Particularly for many of our start-up or smaller companies, a provision like that is really a beautiful regulatory efficiency proposal that doesn’t do anything to change the importance or the soundness of the clinical trial,” said JC Scott, chief advocacy officer for AdvaMed, a medical device industry trade organization. The provision is an example of myriad regulatory reforms of significance to the medical device industry in the 21st Century Cures Act, which Obama signed Dec. 13. The comprehensive legislation streamlines the regulatory process for pharmaceutical and medical device companies, sets medical research policy, and provides federal funding for medical research, including $1.8 billion in new funding for cancer research. “This critical legislation invests more in science and research, removes barriers that stand in the way of modern treatments, and advances personal medicine to ensure that patients can be treated based on their unique characteristics,” said U.S. Rep. Elise Stefanik, R-Willsboro, in a news release.   READ THE REST HERE

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30 Dec

PATIENT-SPECIFIC PLANNING FOR SHOULDER REPLACEMENT

Elizabeth Hofheinz, M.P.H., M.Ed. • Tue, December 27th, 2016

For many years the standard in training airline pilots has been pre-flight simulators. This helps them become more skilled at flying the actual plane. This is a comfortable thought isn’t it? Exactly! Well, recent developments in shoulder replacement surgery allow surgeons to simulate surgery and this benefits not only the patient, but also the hospital. Jon J.P. Warner, M.D. is chief of the Massachusetts General Hospital Shoulder Service and co-Director of the Boston Shoulder Institute. He and his colleagues are bringing clarity to the operating room via patient-specific planning for shoulder replacement.

Dr. Warner told OTW, “Joint replacement is expensive and the results are unpredictable; and unlike total hip and knee surgery, most orthopedic surgeons have limited experience with shoulder replacement surgery. Since shoulder replacement surgery is performed at a volume of <15% hip or knee replacement surgery, 90% of all shoulder replacements in the U.S. are performed by surgeons who do less than 5 procedures each year. Thus these surgeons may not have enough experience to avoid some common problems. These problems may include incorrect size selection and inaccurate placement of the shoulder replacement components.” “For shoulder replacement you must select a size that matches the patient’s anatomy, meaning that you have to have a full complement of instruments and implants on hand. To do a single operation the device manufacturer must deliver roughly $75,000 in inventory of instruments and implants; and if the surgeon opens a tray and doesn’t use it then it’s $100 to sterilize it. This economic reality challenges both the hospital and the company to provide cost-effective care.”   READ THE REST HERE

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30 Dec

FDA Issues List Of Priority Device Guidances For 2017

By Jof Enriquez - December 29, 2016 The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114). CDRH provides three lists: (1) a list of guidance documents that the Agency fully intends to publish (the "A-list"); (2) a list of guidance documents that the Agency intends to publish as resources permit (the "B-list"); and (3) a list of final guidance documents issued in 2007, 1997, 1987, and 1977 subject to focused retrospective review, as well as possible revision or withdrawal. Among the A-list are final guidance documents on medical device cybersecurity, next-generation sequencing-based diagnostic devices, and the use of real-world evidence (RWE) to aid regulatory decision-making. Cybersecurity and RWE also are included in CDRH’s top ten science priorities for 2017, announced in September. Included in the B-list are final guidance documents on unique device identification (UDI) and investigational device exemption (IDE) categories to support CMS coverage decisions. Also included is the draft guidance on electromagnetic compatibility of electrically powered medical devices, developed with the help of early stakeholder input. CDRH says it issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). Several guidance documents that were not published in FY 2016, but were deemed high priority through stakeholder feedback, are now on the annual agenda for FY 2017, according to RAPS. FDA says in a notice in the Federal Register that it welcomes comments on any or all of the guidance documents on the FY 2017 lists, allowing CDRH to better prioritize and more efficiently draft or finalize guidances, and to delete guidance documents that no longer represent the Agency's interpretation, thinking, or policy on a regulatory issue.   READ THE REST HERE

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30 Dec

NuVasive to Resume XLIF Procedures in Japan in First Quarter 2017

SAN DIEGO, CA--(Marketwired - December 29, 2016) - NuVasive, Inc. (NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it received approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW).

Recent guidance from the MHLW requires dilators and associated components used in lateral access spine surgical procedures to be classified in Japan as Class III medical devices. NuVasive's dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in August 2011 with additional sizes approved in January 2014. As previously disclosed, NuVasive submitted its dilator and associated components for reclassification as Class III medical devices, and surgeons had temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.

With this approval from the MHLW, XLIF procedures in Japan will resume in the first quarter of 2017. In connection with the MHLW approval, NuVasive has agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.

"We've worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan," said Jason Hannon, NuVasive's president and chief operating officer. "Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013. As the industry leader in lateral procedures, we take our leadership responsibility seriously and have worked diligently with the MHLW to make XLIF available in Japan again. We thank the MHLW and our surgeon partners in Japan for supporting our efforts in keeping industry-leading innovation available to patients in need."

XLIF is a minimally invasive surgical (MIS) procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. There are over 350 peer-reviewed global journal articles reporting on the XLIF procedure over the last 11 years, which detail the positive outcomes and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.

The Company intends to provide preliminary guidance for 2017 revenue on January 9, 2017 at the J.P. Morgan Healthcare Conference.

About NuVasive

NuVasive, Inc. (NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive's highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA™ platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

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29 Dec

Medtronic Will Experience Stellar Growth Over The Next Five Years

 - December 29, 2016

Summary

Medtronic's share price dropped when the company missed revenue estimates. Recent acquisitions and medical innovations put Medtronic in a strong position. Over the next five years, the company is predicting growth of 7.8% per year. Payouts will increase in 2017.
Dividend investors should jump into Medtronic (NYSE:MDT) now. Today's share price is $71.25, reflecting an overreaction to Medtronic's third quarter earnings report in which the company exceeded earnings per share forecasts, but failed to meet revenue expectations, missing by $160 million. Despite the revenue glitch, which the company ascribed to production holdups, Medtronic's health is better than ever. Over the previous five year period, the company's yearly revenue increased from $16 billion in 2011 to $28 billion in 2015 and should continue to increase over the next five years for a number of reasons.
  READ THE REST HERE

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29 Dec

OrthoArizona – Arizona Hand, Wrist and Elbow Surgeons Expands its Practice by Adding a New Surgeon to Its Practice

PHOENIX, ARIZONA (PRWEB) DECEMBER 20, 2016

The premier hand, wrist and elbow surgery practice in Phoenix, OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons, is expanding its practice with the addition of fellowship-trained hand surgeon.

Ryan A. Odgers, MD brings with him extensive wrist, microvascular and hand surgery experience. He joins the board-certified team at OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons which also includes E. Scott Frankel, MD; Mark J. Leber, MD; Matthew M. Conklin, M.D.; and Richard K. Hinkle, PA-C.

“We're confident that Dr. Odgers will continue the level of excellence we’ve established and are excited that he has joined our team,” said Dr. Mark Leber.

Dr. Odgers assumes his new position at Arizona Hand, Wrist and Elbow Surgeons following fellowship training focused on hand and upper extremity surgery at Integris Baptist Medical Center in Oklahoma City. Prior to his fellowship, Dr. Odgers received a bachelor’s degree in biology from Arizona State University, a medical degree from the University of Oklahoma and completed his residency right here in Phoenix.

For more information about OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons, please call (602) 393-1010 or visit http://azhandwristspecialists.com/. Find out more about OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons on Facebook at https://www.facebook.com/AZHandAndWristSpecialists/.

About OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons The board-certified hand specialists at OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons are trained to diagnose and treat all problems related to the different structures in the hand, wrist, forearm and elbow, treating patients of all ages, from infants to the elderly. Offering unrivaled service on a variety of conditions from industrial injuries to osteoarthritis of the hand, OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons is wholly committed to satisfying the needs of their patients. Whether an issue requires surgery or not, OrthoArizona - Arizona Hand, Wrist and Elbow Surgeons has a team of top-notch, board certified surgeons available to diagnose and treat both emergency injuries and chronic problems.

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