FDA Grants De Novo Clearance for Z-Medica ’s QuikClot Control+ Only Non-Absorbable Hemostatic Dressing for Severe Bleeding in Internal Organ Space
Wallingford, Conn. - Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot Control+ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device.
QuikClot Control+ is the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wound...
Source: JEMS Patient Care - July 13, 2017 Category: Emergency Medicine Authors: Dave Schemelia Tags: Patient Care Industry News Source Type: news
FDA Grants De Novo Clearance for Z-Medica ’s QuikClot Control+ Only Non-Absorbable Hemostatic Dressing for Severe Bleeding in Internal Organ Space
Wallingford, Conn. - Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot Control+ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device.
QuikClot Control+ is the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wound...
Source: JEMS: Journal of Emergency Medical Services News - July 13, 2017 Category: Emergency Medicine Authors: Dave Schemelia Tags: Patient Care Industry News Source Type: news
Z-Medica wins FDA de novo nod for QuickClot Control+
Hemostatic device developer Z-Medica said today it won FDA de novo clearance for its QuickClot Control+, now indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding.
The Wallingford, Conn.-based company touted its QuickClot Control+ as the 1st and only non-absorbable hemostatic dressing with clearance for internal organ space in severely bleeding patients, and added that it may also be used for control of severely bleeding wounds including surgical wounds and traumatic injuries.
“This clearance marks another major milestone in the growth of our company ...
Source: Mass Device - July 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Z-Medica Source Type: news
Onlay Mesh May Help Prevent Incisional Hernia After Midline Laparotomy Onlay Mesh May Help Prevent Incisional Hernia After Midline Laparotomy
Onlay mesh reinforcement significantly reduced the incidence of incisional hernia compared with sublay mesh or primary suture in high-risk patients undergoing midline laparotomy, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 30, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news
Self-inflicted abdominal stab wounds have a higher rate of non-therapeutic laparotomy/laparoscopy and a lower risk of injury - Bugaev N, McKay K, Breeze JL, Arabian SS, Rabinovici R.
BACKGROUND: The profile and management of self-inflicted abdominal stab wounds (SI-ASW) patients is still obscure. METHODS: The National Trauma Data Bank (2012) was queried for adults with abdominal stab wounds (n = 9544). Patients with SI-ASW (n... (Source: SafetyLit)
Source: SafetyLit - June 28, 2017 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
Smith & Nephew touts lowered infection rate in Pico wound therapy trial
This study underscores the importance of PICO single use NPWT in treating patients who have undergone a laparotomy. As surgeons, we are always looking for effective and cost efficient ways to treat patients, and this study demonstrates that PICO single use NPWT can significantly reduce both the incidence of surgical site infection and the length of stay, resulting in a potential reduction in healthcare costs,” Colin Peirce of Limerick, Ireland’s University Hospital said in a prepared statement.
“This study is the latest addition of research that reinforces the importance of PICO Single Use NPWT and the si...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Smith & Nephew Source Type: news
More Patient Education Needed for Gynecologic Robotic Surgery
Women undergoing robotic surgery procedures for gynecologic cancers and nonmalignant conditions report more patient education needs than those undergoing traditional laparotomy. (Source: CancerNetwork)
Source: CancerNetwork - May 8, 2017 Category: Cancer & Oncology Authors: Bryant Furlow Tags: News Oncology Nursing Gynecologic Cancers Conferences/ONS 2017 Source Type: news
Survival Similar With Debulking by Laparotomy, Laparoscopy
Similar three - year survival rates for women with epithelial ovarian cancer undergoing debulking (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - April 10, 2017 Category: Cancer & Oncology Tags: Gynecology, Oncology, Surgery, Journal, Source Type: news
Contemporary damage control surgery outcomes: 80 patients with severe abdominal injuries in the right upper quadrant analyzed - Hommes M, Chowdhury S, Visconti D, Navsaria PH, Krige JE, Cadosch D, Nicol AJ.
BACKGROUND: Damage control laparotomy (DCL) is a well-established surgical strategy in the management of the severely injured abdominal trauma patients. The selection of patients by intra-abdominal organs involvement for DCL remains controversial. The aim ... (Source: SafetyLit)
Source: SafetyLit - March 3, 2017 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
The hidden story of innovation: Charity Hospital, Angola Prison, and the challenging of surgical dogma - Greiffenstein P, Hastings PR.
The late 1960s was a period of significant upheaval of social, cultural, and scientific norms. The generally accepted notion of mandatory laparotomy for all penetrating abdominal injuries was among those norms being called into question across the country ... (Source: SafetyLit)
Source: SafetyLit - February 27, 2017 Category: Global & Universal Tags: Commentary Source Type: news
Olympus wins FDA nod & launches new power morcellator with tissue capture
Olympus (TYO:7733) said today it won FDA 510(k) clearance for its next-gen laparoscopic PK morcellator with tissue containment designed as a laparoscopic surgery option to avoid open hysterectomy and myomectomy for uterine fibroid removal
The company’s newly launched morcellator includes the company’s PneumoLiner contained tissue extraction system.
“Contained tissue extraction is continually evolving. As surgeons, it is our duty to evaluate potential solutions to the surgical challenges we face in clinical practice. We are pleased that Olympus has taken the initiative to develop a unique and well tested ...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Olympus Source Type: news
Mortality in trauma patients with active arterial bleeding managed by embolization or surgical packing: an observational cohort study of 66 patients - Froberg L, Helgstrand F, Clausen C, Steinmetz J, Eckardt H.
OBJECTIVE: Exsanguination due to coagulopathy and vascular injury is a common cause of death among trauma patients. Arterial injury can be treated either by angiography and embolization or by explorative laparotomy and surgical packing. The purpose of this... (Source: SafetyLit)
Source: SafetyLit - September 2, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
Sexual and physical abuse and gynecologic disorders - Schliep KC, Mumford SL, Johnstone EB, Peterson CM, Sharp HT, Stanford JB, Chen Z, Backonja U, Wallace ME, Louis GMB.
STUDY QUESTION Is sexual and/or physical abuse history associated with incident endometriosis diagnosis or other gynecologic disorders among premenopausal women undergoing diagnostic and/or therapeutic laparoscopy or laparotomy regardless of clinical indic... (Source: SafetyLit)
Source: SafetyLit - August 14, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
Diagnostic accuracy of laparoscopy following computed tomography (CT) scanning for assessing the resectability with curative intent in pancreatic and periampullary cancer
This Review concludes that diagnostic laparoscopy may decrease the rate of unnecessary laparotomy in people with pancreatic and periampullary cancer found to have resectable disease on CT scan. On average, using diagnostic laparoscopy with biopsy and histopathological confirmation of suspicious lesions prior to laparotomy would avoid 21 unnecessary laparotomies in 100 people in whom resection of cancer with curative intent is planned. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - July 27, 2016 Category: Consumer Health News Source Type: news
Mayo Clinic PathWays: What's the Diagnosis?
This week, Drs. Xiaotun Zhang and Debra A. Bell discuss the case of a woman presenting with lower abdominal pain. An emergent exploratory laparotomy revealed a ruptured left ovarian mass. After reviewing the immunohistochemical stains, ovarian large cell neuroendocrine carcinoma was diagnosed. View the case and make your diagnosis. Learn more about Mayo Clinic PathWays. (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - July 26, 2016 Category: Databases & Libraries Source Type: news
