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Rotation Medical touts regenerative rotator cuff repair data
This study is further evidence that the Rotation Medical rotator cuff system has the potential to transform the treatment of rotator cuff disease. Our bioinductive implant addresses both the biomechanics and biology required to heal a rotator cuff tendon tear, preventing rotator cuff tears from becoming larger over time, reducing the incidence of re-tears and, in some cases, shortening patient recovery time,” CEO Martha Shadan said in prepared remarks. In August, Rotation Medical said that it added $12 million to a Series B round that’s already brought in $27 million. The company said existing investors New Ente...
Source: Mass Device - September 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Orthopedics Rotation Medical Inc. Source Type: news

China ’ s Microport puts $15m into Lombard Medical
Lombard Medical Technologies (NSDQ:EVAR) said today that China’s MicroPort Orthopedics invested $15 million as part of a partnership deal between the 2 companies. Through the partnership, Lombard will seek to accelerate commercialization of its Arofix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as well as a license to manufacture the products for the Chinese market. As part of the deal, Microport and Lombard said they entered a component supply manufacturing deal, with Microport manufacturing components for t...
Source: Mass Device - December 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Mergers & Acquisitions Stent Grafts Vascular Lombard Medical Technologies MicroPort Scientific Source Type: news

Efficacy and safety of NBCA (n-butyl-2-cyanoacrylate) medical adhesive for patch fixation in totally extraperitoneal prosthesis (TEP): a prospective, randomized, controlled trial.
CONCLUSIONS: The use of NBCA medical adhesive for patch fixation in TEP is effective and safe. PMID: 28272716 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - March 10, 2017 Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research

Amniox Medical lands DoD contract for Neox, Clarix products
Amniox Medical said yesterday it landed a Federal Supply Schedule contract for its Neox and Clarix regenerative product lines with the US Military Health System. The Neox wound allograft is designed for use as a wound covering for dermal ulcers and defects, while its Clarix regenerative matrix is indicated for use as a surgical covering, wrap or barrier during orthopedic surgery and soft tissue repair, Atlanta-based Amniox said. Amniox said that the contract will serve all US Department of Defense institutions, and the company will partner exclusively with veteran-owned small business Alliant Healthcare to provide the pro...
Source: Mass Device - April 18, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Amniox Medical Source Type: news

Rotation Medical release initial results for ‘ bioinductive ’ shoulder implant
Rotation Medical touted initial data today from the Rebuild registry of its bioinductive implant at the annual meeting of the Arthroscopy Association of North America. Interim results from the 1st 200 patients demonstrated significantly less post-operative pain and use of narcotics in patients who received the bioinductive implant, as well as less sling time, faster return to function and better overall shoulder rating. Patients in the registry reported feeling better 6 months after receiving the implant than those who received traditional treatment did at 2 years. The registry is slated to follow up to 300 patients. ̶...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Implants Orthopedics Rotation Medical Inc. Source Type: news

Edwards Lifesciences acquires mitral repair dev Harpoon Medical for $100 million
Edwards Lifesciences (NYSE:EW) said today it acquired mitral valve repair developer Harpoon Medical for $100 million in cash, with the potential for an additional $150 million in milestone payments over 10 years. Harpoon is developing a system designed to enable echo-guided repair of mitral valve regurgitation through the stabilization of prolapse leaflets to restore coaptation and valve function. The device is currently investigational, though Harpoon is hopeful it will receive CE Mark approval in the European Union in the near future. “We believe the addition of Harpoon Medical’s technology and talented team...
Source: Mass Device - December 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions Replacement Heart Valves Edwards Lifesciences Harpoon Medical Source Type: news

IlluminOss Medical wins de novo nod from FDA for bone stabilization system
The FDA last month granted de novo clearance to the photodynamic bone stabilization system developed by IlluminOss Medical. The IlluminOss device uses a light-curable polymer, delivered in an expandable balloon catheter, to stabilize bone fractures. In a Dec. 19 letter to the East Providence, R.I.-based company, the FDA granted de novo clearance for an indication for “skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.” The federal safety watchdog said it also concluded that the IlluminOss device is Class II, u...
Source: Mass Device - January 23, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance IlluminOss Medical Inc. Source Type: news

Wright Medical, KFx settle patent spat, ink licensing deal
KFx Medical said today it and Wright Medical (NSDQ:WMGI) agreed to dismiss patent litigation over rotator cuff repair patents between the companies and ink a licensing deal. Through the newly inked deal, Memphis, Tenn.-based Wright Medical and its affiliates will have the right to promote the use of products and techniques for knotless double row rotator cuff repair, which KFx owns the patent for, for the life of those patents. Terms of the deal were not disclosed. “We are proud to have our innovation recognized by Wright. Previously we announced our licensing agreements with Smith & Nephew, Inc., Mitek, a John...
Source: Mass Device - March 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Orthopedics Patent Infringement KFx Medical wrightmedical Source Type: news

Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentinel d...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Gore picks up stealthy Pipeline Medical and its mitral repair program
W.L. Gore & Assoc. said today that it acquired stealthy Pipeline Medical Technologies and its mitral repair program for an undisclosed amount. Santa Rosa, Calif.-based Pipleline is developing a transcatheter device designed to duplicate the efficacy and outcomes found when mitral valve chords are repaired via open heart surgery. Gore said it plans to run the company as a wholly owned subsidiary under the Pipeline brand. “The addition of Pipeline’s investigational technology and talented associates bolsters our continued ambition to improve patients’ lives by offering physicians innovative treatment s...
Source: Mass Device - September 6, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Mergers & Acquisitions Replacement Heart Valves Pipeline Medical Technologies W.L. Gore & Associates Source Type: news

Teleflex picks up Essential Medical and its Manta vascular closure device
Teleflex (NYSE:TFX) said yesterday that it acquired Essential Medical and its Manta vascular closure device for an unspecified amount. Manta is designed to close punctures at femoral arterial access sites after catheterization procedures, including transcatheter aortic valve replacements, endovascular treatment of abdominal aortic aneurysms, ventricular assist procedures and balloon aortic valvuloplasties. Exton, Pa.-based Essential won CE Mark approval in the European Union for Manta in July 2016 and is seeking pre-market approval from the FDA. The federal safety watchdog granted an investigational device exemptionÂ...
Source: Mass Device - October 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Vascular Wall Street Beat Essential Medical Devices Teleflex Source Type: news

Natus Medical deals Medix division to employees
Natus Medical (NSDQ:BABY) said yesterday that it inked a deal to sell its subsidiary Medix Medical Devices in an employee-led buyout. In the sale, Pleasanton, Calif.-based Natus Medical said it is offloading the Medix line of products including incubators and warmers. Natus said that Medix will continue to distribute the Medix products as well as the previously distributed line of Natus products and other third party products in Argentina and Venezuela. The separated Medix will also provide customer service, sales, customer support and warranty and repair services for the products. “This divestiture is an important ...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Natus Medical Inc. Source Type: news

Clinical outcomes associated with pathogenic genomic instability mutations in prostate cancer: a retrospective analysis of US pharmacy and medical claims data.
Conclusion: PC patients carrying ≥1 pathogenic DNA instability mutation, and DRD mutation carriers specifically, had higher clinical burden than non-mutation carriers. Targeted therapies for these patients are needed to reduce clinical burden and associated healthcare resource utilization. PMID: 31352849 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - July 31, 2019 Category: Health Management Tags: J Med Econ Source Type: research

Top 10 Medical Innovations for 2020, According to Cleveland Clinic Top 10 Medical Innovations for 2020, According to Cleveland Clinic
A new osteoporosis drug, minimally invasive mitral valve surgery, immunotherapy for peanut allergies, and biologics in orthopedic repair are among the advances predicted to have the greatest impact in 2020.Medscape Medical News
Source: Medscape Medical News Headlines - November 7, 2019 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news

IoT Based Predictive Maintenance Management of Medical Equipment
AbstractTechnological advancements are the main drivers of the healthcare industry as it has a high impact on delivering the best patient care. Recent years witnessed unprecedented growth in the number of medical equipment manufactured to aid high-quality patient care at a fast pace. With this growth of medical equipment, hospitals need to adopt optimal maintenance strategies that enhance the performance of their equipment and attempt to reduce their maintenance costs and effort. In this work, a Predictive Maintenance (PdM) approach is presented to help in failure diagnosis for critical equipment with various and frequent ...
Source: Journal of Medical Systems - February 19, 2020 Category: Information Technology Source Type: research