Montag, 29. Januar 2018

Medrobotics Corporation Receives FDA Clearance for the Company´s Flexible Transabdominal and Transthoracic Robotic Scope

MedDEV News (Medrobotics Corp). Medrobotics, a medical robotics company, announced FDA regulatory clearance to market the Flex Robotic System for robot- assisted visualization in general surgical, gynecological and thoracic procedures in the US

This clearance reaffirms the Company’s progress to develop transformative products for single-port general, gynecological, thoracic and urological surgeries. “With this new FDA indication, the use of Medrobotics’ flexible robotic technology extends beyond natural orifices,” said CEO Samuel Straface. “This clearance is a vital step in our commitment to minimize the impact of surgery by offering less invasive procedures through a single incision in the abdomen or thoracic cavity versus the multiple incisions that are currently required.”

Medrobotics Corporation is a medical device company headquartered in Raynham, Massachusetts. With Flex Robotic System, the firm markets the world’s first and only robotic surgical platform which provides “scarfree access” to hard-to-reach anatomy in otolaryngology and colorectal procedures. The System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point while operating in hard-to-reach anatomical locations that might otherwise be inaccessible with straight, rigid surgical tools.

The award-winning Flex Robotic System has been widely recognized for advances in surgical robotic technology, including Best-in-Show at the 2016 Medical Design Excellence Awards (MDEA) and a Best New Product at the 2017 Edison Awards.

Donnerstag, 25. Januar 2018

ADAC Luftrettung täglich 150 Mal im Einsatz

MedDEV News. Die Hubschrauber der gemeinnützigen ADAC Luftrettung sind im Jahr 2017 zu rund 54.500 Notfällen gestartet. Damit blieb die Zahl der Einsätze gegenüber dem Vorjahr nahezu unverändert. Im Durchschnitt hoben die ADAC Luftrettungscrews rund 150 Mal am Tag ab. 

Die Zahl der versorgten Patienten lag mit mehr als 49.000 ebenfalls annähernd auf Vorjahresniveau. Bei ihren oft lebensrettenden Einsätzen legten die ADAC Rettungshubschrauber rund 3,6 Millionen Kilometer zurück - oder flogen fast 90 Mal um die Erde. Die durchschnittliche Flugzeit bei einem Einsatz betrug rund 30 Minuten. 

2017 zu 54.491 Notfällen gestartet und 3,6 Millionen Kilometer zurückgelegt 

Einsatzursache Nummer eins waren bei den Rettungseinsätzen mit fast 50 Prozent erneut internistische Notfälle wie akute Herz- und Kreislauferkrankungen. In je zwölf Prozent der Fälle wurden die Lebensretter zu neurologischen Notfällen (zum Beispiel Schlaganfall) sowie zu Freizeitunfällen (Sport- und häusliche Unfälle) gerufen. Bei zehn Prozent war ein Verkehrsunfall die Ursache. 

Die Liste der Einsatzorte in den Bundesländern führt Bayern mit 12.971 Einsätzen an, hier befinden sich acht der 37 ADAC Luftrettungsstationen. Dahinter folgen Rheinland-Pfalz mit 7.325, Nordrhein-Westfalen mit 6.425 und Niedersachsen mit 5.381 Einsätzen. Gerade in ländlichen Regionen, wo es oft an Notärzten mangelt, ist der Rettungshubschrauber häufig der schnellste und einzige Weg, den Notarzt zeitgerecht zum Patienten zu bringen und diesen schonend in eine geeignete Klinik zu transportieren. 

Berlin vorne - deutlich mehr Flüge in der Dämmerung unabdingbar

Bei den Städten liegt die ADAC Luftrettungsstation in Berlin vorne. "Christoph 31" flog in der Region zu 3.331 Notfällen und ist damit der Rettungshubschrauber mit den weltweit meisten Luftrettungseinsätzen pro Tag.

Donnerstag, 18. Januar 2018

DWG Nachlese

Smart Implants 2018/IV

With this new series of short publications MedDEV News wants to introduce various concepts of SMART IMPLANTS.
For better bone, use softer scaffolds
MedDEV News ( Large segmental gaps in bone caused by trauma or disease are typically treated with bone grafts and stiff scaffolds to hold the fractured bone in place, but sometimes these defects fail to heal. To optimize bone regeneration, Pobloth and colleagues modified titanium-mesh scaffold designs to provide specific strains and stresses within the fracture environment. In sheep with critical-sized segmental defects, scaffolds that reduced stress shielding around tibial fractures enhanced bone bridging compared to stiffer scaffolds and shielding plates. Scaffolds can be tuned to evoke specific mechanical and biological responses within bone defects, which could help guide regeneration.
Three-dimensional (3D) titanium-mesh scaffolds offer many advantages over autologous bone grafting for the regeneration of challenging large segmental bone defects. Our study supports the hypothesis that endogenous bone defect regeneration can be promoted by mechanobiologically optimized Ti-mesh scaffolds. Using finite element techniques, two mechanically distinct Ti-mesh scaffolds were designed in a honeycomb-like configuration to minimize stress shielding while ensuring resistance against mechanical failure. Scaffold stiffness was altered through small changes in the strut diameter only. Honeycombs were aligned to form three differently oriented channels (axial, perpendicular, and tilted) to guide the bone regeneration process. The soft scaffold (0.84 GPa stiffness) and a 3.5-fold stiffer scaffold (2.88 GPa) were tested in a critical size bone defect model in vivo in sheep. To verify that local scaffold stiffness could enhance healing, defects were stabilized with either a common locking compression plate that allowed dynamic loading of the 4-cm defect or a rigid custom-made plate that mechanically shielded the defect. Lower stress shielding led to earlier defect bridging, increased endochondral bone formation, and advanced bony regeneration of the critical size defect. This study demonstrates that mechanobiological optimization of 3D additive manufactured Ti-mesh scaffolds can enhance bone regeneration in a translational large animal study. 

Dienstag, 16. Januar 2018

Smart Implants 2018/III

With this new series of short publications MedDEV News wants to introduce various concepts of SMART IMPLANTS.

Matthew K. Dion et al.:  Smart Orthopaedic Implants: Applications in Total Knee Arthroplasty

MedDEV News. Total knee arthroplasty is a common orthopaedic procedure conducted in the United States with approximately 700,000 surgeries performed annually. A common complication following total knee arthroplasty is anterior knee pain which affects tens to hundreds of thousands of people each year.
The exact mechanism that leads to anterior knee pain remains unknown, but improper component selection may cause pathologic loading of the knee which leads to pain. Measuring loads in the knee to elucidate the mechanisms underlying anterior knee pain remains a challenge because the joints are so small.
Using novel wireless sensor technology, we have developed and validated the first “smart” patellar implant capable of measuring force magnitude and force distribution in the knee. Implantable force sensors were calibrated and tested through the range of physiologic loading.
Three sensors were then interfaced with a Zimmer patellar implant and placed into a custom loading apparatus. The smart patellar implant was then incrementally loaded from 0-500 N. Sensor signals were all recorded simultaneously in real time to measure the load across the patellofemoral joint.
Results demonstrated that the smart patellar implant could accurately measure the load being transmitted across the simulated patellofemoral joint.
© 2016 Matthew K. Dion, John Drazan, Khaled Abdoun, Sarah Giddings, Vishal Desai, Nathaniel C. Cady, Reena Dahle, Jared T. Roberts and Eric H. Ledet. This open access article is distributed under a Creative Commons Attribution (CC-BY)

Donnerstag, 11. Januar 2018

Smart Implants 2018/II

With this new series of short publications MedDEV News wants to introduce various concepts of SMART IMPLANTS.

Smart Hips can reduce the number of surgical interventions post-op

MedDEV News ( To monitor the real-time performance of bone implants is the challenge of "Smart Hip," an innovative medical device that aims to reduce the number of surgical interventions in the hip area and regenerate bone tissue by using non-evasive methods. The device - developed by an engineering doctoral student from the University of Porto in Portugal - has already been successfully tested on animals.
It is estimated that today there are about a million hip joint surgeries in Europe and USA, and that 5% to 10% of these surgeries eventually generate further health problems, which usually requires additional surgery. But a solution to this problem may now be closer.
Clara Frias -- a 29-year-old PhD in Engineering Sciences from the Faculty of Engineering of University of Porto (FEUP) and researcher at the Institute of Mechanical Engineering and Industrial Management (INEGI) -- created this "intelligent" hip device to detect an implant's eventual problems and to stimulate bone growth, thus improving the quality of life for patients and reducing the risk of further surgery.
The Smart Hip is a network of capsules, measuring sensors and actuators that are placed on the hip implant. Once activated by the doctor -- through a computer connected to a Bluetooth device -- the "Smart Hip" components send information that can help prevent eventual problems after surgery.
In addition, says Clara Frias, "a network of actuators capable of stimulating bone growth at the implant's surface is being developed." This network, as well as the network of sensors, will be externally controlled through a wireless system by a physician. The concept has been validated in cell studies and was recently tested in animals -- with "very encouraging results," adds the researcher. Patented by the University of Porto, the Smart Hip was developed in collaboration with researchers from the INEGI, in partnership with the Universities of Aveiro, Évora and Trás-os-Montes and Alto Douro.

Dienstag, 9. Januar 2018


With this new series of short publications MedDEV News wants to introduce various concepts of SMART IMPLANTS. We will start with a spinal implant that has the possibility to reduce post-operative CT scans.

Smart Spinal Implant indicates Progress in Fusion 

MedDEV News (ZYK). Intellirod Spine’s innovative wireless strain monitoring system will provide spine surgeons objective data on rod strain as they assess postoperative fusion progress. This new strain data in conjunction with current methods has the potential to improve outcomes and lower postoperative healthcare costs.

The patented Intellirod System includes a titanium/zirconia ceramic, strain sensing device, which includes radio-frequency identification (RFID) technology, intended to enable access to strain measurement values, incorporating a passive transponder, inserter and scanner. The transponder attaches to any commercially available, corrective spinal system using 5.5 mm cobalt chrome or titanium alloy rods in corrective spinal surgeries. The transponder is used only to acquire rod strain values and a unique device identification code, which is read by the scanner, providing objective readings of the mechanical strain during the correction to be used in conjunction with standard of care clinical and radiographic assessments. 

Intellirod Spine was founded by renowned spine surgeon Rolando M. Puno, M.D. and professors from the University of Louisville. The company is developing a wireless implantable microelectronic spinal rod strain sensor. This innovative strain monitoring system will allow spine surgeons to objectively assess the strain on implanted spinal fusion rods.

Samstag, 6. Januar 2018

Happy New Year 2018

HAPPY NEW YEAR from Medical Device Monthly News and best wishes for a successful and healthy year 2018 with good ideas and interesting projects!