The evolution of PET imaging in renal, bladder, upper urinary tract urothelial, testicular and penile carcinoma - Today's impact, tomorrow's potential
Expert Rev Med Devices. 2023 Dec 10. doi: 10.1080/17434440.2023.2293919. Online ahead of print.ABSTRACTINTRODUCTION: the advancement of hybrid PET/CT or PET/MRI imaging for non-prostate genitourinary cancers has not experienced the rapid progress of prostate cancer. Nevertheless, these neoplasms are aggressive and reliable imaging plays a pivotal role in enhancing patients' quality of life and prognosis.AREAS COVERED: the main evidence regarding [18F]FDG and non-[18F]FDG PET/CT or PET/MRI in non-prostate uro-oncological malignancies are summarized and discussed. Moreover, potential future directions concerning PET imaging ...
Source: Expert Review of Medical Devices - December 10, 2023 Category: Medical Devices Authors: Luca Urso Matteo Bauckneht Domenico Albano Sotirios Chondrogiannis Gaia Grassetto Francesco Lanfranchi Francesco Dondi Giuseppe Fornarini Massimo Lazzeri Laura Evangelista Source Type: research
The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study
CONCLUSION: This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.PMID:38041629 | DOI:10.1080/17434440.2023.2291454 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 2, 2023 Category: Medical Devices Authors: Olivia McDermott Breda Kearney Source Type: research
The value of using real-world evidence as a source of clinical evidence in the European medical device Regulations: a mixed methods study
CONCLUSION: This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.PMID:38041629 | DOI:10.1080/17434440.2023.2291454 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 2, 2023 Category: Medical Devices Authors: Olivia McDermott Breda Kearney Source Type: research
Transcatheter aortic valve durability, predictors of bioprosthetic valve dysfunction, longer-term outcomes - a review
This article explores the main causes of bioprosthetic valve dysfunction (BVD) based on pathophysiology and available data, and reviews possible predictors of BVD including prosthesis-related, procedure-related, and patient-related factors. An emphasis is made on affectable predictors, which could potentially be targeted with prevention management and improve valve durability. A literature search of online medical databases was conducted using relevant key words and dates; significant clinical trials were identified. A brief overview of important randomized controlled trials with mid to long-term follow-up is included in t...
Source: Expert Review of Medical Devices - November 30, 2023 Category: Medical Devices Authors: Šolc Abigail Johanna L ínková Hana Source Type: research
The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations
Expert Rev Med Devices. 2023 Nov 30. doi: 10.1080/17434440.2023.2288911. Online ahead of print.ABSTRACTINTRODUCTION: The use of tissue expanders (TE) in post-mastectomy breast reconstruction is a widely accepted practice, especially in patients desiring implant-based breast reconstruction. It has become the standard of care to perform a two-staged breast reconstruction using tissue expanders for the past 50 years due to its reliability, safety, cost-effectiveness, and versatility. Due to its popularity, there are numerous types and features of breast tissue expanders and various surgical approaches available for plastic su...
Source: Expert Review of Medical Devices - November 30, 2023 Category: Medical Devices Authors: Min-Jeong Cho Rana V Farhadi David W Nash Joseph Kaleeny Stephen P Povoski Albert H Chao Source Type: research
Transcatheter aortic valve durability, predictors of bioprosthetic valve dysfunction, longer-term outcomes - a review
This article explores the main causes of bioprosthetic valve dysfunction (BVD) based on pathophysiology and available data, and reviews possible predictors of BVD including prosthesis-related, procedure-related, and patient-related factors. An emphasis is made on affectable predictors, which could potentially be targeted with prevention management and improve valve durability. A literature search of online medical databases was conducted using relevant key words and dates; significant clinical trials were identified. A brief overview of important randomized controlled trials with mid to long-term follow-up is included in t...
Source: Expert Review of Medical Devices - November 30, 2023 Category: Medical Devices Authors: Šolc Abigail Johanna L ínková Hana Source Type: research
The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations
Expert Rev Med Devices. 2023 Nov 30. doi: 10.1080/17434440.2023.2288911. Online ahead of print.ABSTRACTINTRODUCTION: The use of tissue expanders (TE) in post-mastectomy breast reconstruction is a widely accepted practice, especially in patients desiring implant-based breast reconstruction. It has become the standard of care to perform a two-staged breast reconstruction using tissue expanders for the past 50 years due to its reliability, safety, cost-effectiveness, and versatility. Due to its popularity, there are numerous types and features of breast tissue expanders and various surgical approaches available for plastic su...
Source: Expert Review of Medical Devices - November 30, 2023 Category: Medical Devices Authors: Min-Jeong Cho Rana V Farhadi David W Nash Joseph Kaleeny Stephen P Povoski Albert H Chao Source Type: research
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability and unmet clinical needs
Expert Rev Med Devices. 2023 Nov 29. doi: 10.1080/17434440.2023.2289691. Online ahead of print.ABSTRACTINTRODUCTION: Sustaining a healthy weight is a great challenge and obesity has become a pandemic with associated risk of co-morbidities, hence a major concern for public health bodies worldwide. Surgical interventions, such as bariatric surgery, have shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloo...
Source: Expert Review of Medical Devices - November 29, 2023 Category: Medical Devices Authors: Sara Ameen Hamid A Merchant Source Type: research
Technology assistance in primary total knee replacement: hype or hope?
Expert Rev Med Devices. 2023 Nov 22:1-4. doi: 10.1080/17434440.2023.2287576. Online ahead of print.ABSTRACTINTRODUCTION: Total knee replacement (TKR) reduces pain, it increases quality of life and it generally lasts a long time with revision rates of less than 5% at 10 years. Some authors have suggested that outcomes may be further improved by technology assistance.AREAS COVERED: Technology assistance in primary TKR includes technologies such as navigated TKR, patient specific instrumentation TKR and robotic TKR.EXPERT OPINION: In general, technology assistance results in higher accuracy of component positioning and alignm...
Source: Expert Review of Medical Devices - November 22, 2023 Category: Medical Devices Authors: Bart G Pijls Source Type: research
Assessing the Sentimag system for guiding sentinel node biopsies in patients with breast cancer
Expert Rev Med Devices. 2023 Nov 21:1-9. doi: 10.1080/17434440.2023.2284790. Online ahead of print.ABSTRACTINTRODUCTION: Sentinel lymph node biopsy for breast cancer is a method to localize and excise the first draining lymph node from an invasive cancer of the breast. The histopathologic evaluation of the sentinel lymph node is used for predicting recurrence and survival and thus, guiding oncologists for treatment-decision making to administer adjuvant therapies. The ability to identify the sentinel node depends on methods to map lymphatic drainage from the breast to the sentinel node and accurately discriminate that node...
Source: Expert Review of Medical Devices - November 22, 2023 Category: Medical Devices Authors: Hira Abidi Richard J Bold Source Type: research
Technology assistance in primary total knee replacement: hype or hope?
Expert Rev Med Devices. 2023 Nov 22:1-4. doi: 10.1080/17434440.2023.2287576. Online ahead of print.ABSTRACTINTRODUCTION: Total knee replacement (TKR) reduces pain, it increases quality of life and it generally lasts a long time with revision rates of less than 5% at 10 years. Some authors have suggested that outcomes may be further improved by technology assistance.AREAS COVERED: Technology assistance in primary TKR includes technologies such as navigated TKR, patient specific instrumentation TKR and robotic TKR.EXPERT OPINION: In general, technology assistance results in higher accuracy of component positioning and alignm...
Source: Expert Review of Medical Devices - November 22, 2023 Category: Medical Devices Authors: Bart G Pijls Source Type: research
