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Source: Mass Device
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Total 23 results found since Jan 2013.
Baxter touts Hemopatch, Floseal study results
Baxter (NYSE:BAX) today presented results from studies of its Hemopatch and Floseal products, touting reductions in costs and hospital stays in both trials.
Results from studies of the devices were presented this week at the International Society for Pharmacoeconomics and Outcomes Research Europe 2018 meeting, the Chicago-based company said.
In a retrospective observational analysis exploring pancreaticoduodenectomies which used the company’s Hemopatch hemostatic-sealant, investigators in Spain found that the device “might be an effective and cost-beneficial additional treatment compared to the Standard of Car...
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Surgical Baxter Source Type: news
BARDA adds $26m to Stratatech ’ s StrataGraft development deal
Mallinckrodt‘s (NYSE: MNK) Stratatech has won an additional $26 million in Project BioShield funding from the the U.S. Biomedical Advanced Research and Development Authority to support pediatric studies of its StrataGraft engineered skin tissue.
The funding will support continued development of the StrataGraft as a potential medical countermeasure for large-scale burn incidents, U.K.-based Mallinckrodt said. BARDA previously supplied funding to Stratatech during its Phase 3 trial of the Stratagraft in adults, which explored the safety and efficacy of the device in promoting autologous skin regeneration of complex ...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Regenerative Medicine Wound Care Mallinckrodt Stratatech Corp. Source Type: news
Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat
Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.
The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.
“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Wound Care gel-e Source Type: news
Cook Medical loses Houston-based IVC suit, plans to appeal
Cook Medical said today it lost a suit related to its Celect vena cava filters in Houston, but that it plans to appeal the decision.
The ruling came from a jury in Houston, which ruled in favor of a plaintiff, though the Bloomington, Ind.-based company did not release any detailed information related to the case.
“We are dedicated to providing life-saving treatment options for patients and will continue to defend all of our IVC filters. Our filters have saved thousands of lives, are clinically successful and are critical to patient well-being,” Cook Medical vascular division VP Mark Breedlove said in a prep...
Source: Mass Device - May 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Vascular Cook Medical Source Type: news
Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.
The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release.
“We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a di...
Source: Mass Device - May 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Cook Medical Source Type: news
Baxter inks partnership deal with International Society of Nephrology
Baxter (NYSE:BAX) said today it inked a partnership deal with the International Society of Nephrology looking to advance awareness and therapy for patients with chronic kidney disease, primarily in low and middle-income countries where the disease is growing the fastest.
In the collaborative partnership , Deerfield, Ill.-based Baxter and the ISN will look to support further therapy research and education about chronic kidney disease, while also looking to develop better care models at lower costs.
“ISN and Baxter’s collaboration aims to address the urgent and growing challenge kidney disease is causing healthcare ...
Source: Mass Device - May 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Baxter Source Type: news
Baxter closes $153m hemostat, sealant asset buy from Mallinckrodt
Baxter (NYSE:BAX) said today that it closed the $153 million acquisition of hemostat and sealant assets from Mallinckrodt Pharmaceuticals (NYSE:MNK).
Baxter announced in January its plan to acquire the stand-alone recombinant thrombin Recothrom and Preveleak surgical sealant for vascular reconstruction.
“We are excited to add both Recothrom and Preveleak to our portfolio of hemostats and sealants to offer surgeons additional options that address different situations when intraoperative bleeding can occur,” advanced surgery president Wil Boren said in prepared remarks. “Our top priority right now is wor...
Source: Mass Device - March 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Surgical Vascular Wall Street Beat Baxter Mallinckrodt Source Type: news
Axiostat is India ’ s first entry on the U.S. hemostat market
Indian medical device maker Axio Biosolutions became the first Indian company with a wound care product cleared by the FDA, according to a press release from the company posted yesterday.
The federal watchdog granted 510(k) clearance to Axio’s Axiostat chitosan hemostatic dressing, which is cleared as an over-the-counter product to stop external bleeding.
The dressing is designed to stop uncontrollable bleeding within two to three minutes of application, and is used by the Indian armed forces, the company said.
“The FDA clearance of Axiostat in the US is a major milestone in our journey so far. This is a valida...
Source: Mass Device - March 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Blood Management Regulatory/Compliance Wound Care axiobiosolutions Source Type: news
Tricuspid repair firm 4Tech taps ex-Boston Scientific execs for CEO, CMO | Personnel Moves for Feb. 27, 2018
4Tech said last week that it named a pair of BSX veterans as its new CEO and CMO, with onetime chief Mike Ennen stepping away for “family reasons.”
Galway, Ireland-based 4Tech said former Boston transcatheter aortic valve GM Tom Fleming is slated to take the reins from Thoratec vet Ennen as president & CEO in March. The company, which is developing the TriClinch Coil transcatheter tricuspid valve repair device, also said that Dr. Keith Dawkins, Boston’s ex-global medical chief, was named CMO effective Feb. 22.
Z-Medica lures ex-Hologic COO Compton
Z-Medica said it named former Hologic (NSDQ:HOLX...
Source: Mass Device - February 27, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Wall Street Beat 4Tech Check-Cap CHF Solutions Inc. imaginmedical imagionbiosystems Invacare LimFlow orthosalespartners personnel-moves Teleflex Source Type: news
Baxter buys Mallinckrodt ’ s Recothrom, Preveleak sealants for $153m
Baxter (NYSE:BAX) said today it inked an agreement with Mallinckrodt Pharmaceuticals (NYSE:MNK) to acquire its Recothrom and Preveleak hemostat and sealant products for approximately $153 million up front with a potential for contingent payments in the future.
Mallinckrodt’s Recothorm is a stand-alone recombinant thrombin-based product with indications as an aid to hemostasis to control oozing blood and minor bleeding from capillaries and small venules when control of bleeding by standard surgical techniques is ineffective or impractical.
The Preveleak sealant is designed to seal suture holes during surgical repai...
Source: Mass Device - January 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Surgical Baxter Mallinckrodt Source Type: news
J & J ’ s Ethicon launches ProxiSure laparoscopic suturing device
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it launched the ProxiSure laparoscopic suturing device.
Ethicon said the device features its endomechanical, suture and curved needle technologies to improve suturing precision in tight spaces. The device allows surgeons to reach desired angles, control bites and secure nots during suturing and knot tying to reduce the risk of needle loss, the company added.
“With the patient’s health at the forefront of our thinking, we aimed to introduce a suturing device that will help reduce the margin of error in minimally-invasive surgery. Surgeons will now b...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Ethicon johnsonandjohnson Source Type: news
How slugs are creating better medical adhesives
[Image from Jianya Li, Adam D. Celiz, David J. Mooney]Slug mucus is the inspiration behind a new adhesive to close surgical wounds and reduce the use of surgical staples, according to new research out of Harvard.
Some of the current adhesives on the market can be toxic and stick together tissues weakly. Some can’t be used in wet environments altogether, which can pose a problem for closing tissues in the body. Harvard University engineering researcher Jianya Li and his team used the defensive mucus secreted by slugs to develop a surgical glue that addresses the challenges associated with previous adhesives.
Li and his te...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Research & Development Surgical hemostat MedTech surgical adhesive Source Type: news
Slug slime inspires new surgical glue
(Reuters) – Scientists have developed an experimental surgical glue inspired by the mucus secreted by slugs that could offer an alternative to sutures and staples for closing wounds.
While some medical glues already exist, they often adhere weakly, are not particularly flexible and frequently cannot be used in very wet conditions.
To get around those problems, a group of scientists from Harvard and other research centers decided to learn from slugs, which – as well as making slime to glide on – can produce extremely adhesive mucus as a defense mechanism.
The slugs’ trick is to generate a substance t...
Source: Mass Device - July 28, 2017 Category: Medical Devices Authors: MassDevice Tags: Research & Development Surgical Wound Care Source Type: news
FDA clears Ethicon ’ s Surgicel powdered hemostat
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won FDA approval for its Surgicel powder absorbable hemostat designed as an adjunctive hemostatic solution to control continuous oozing on broad or raw surfaces.
The Surgicel powdered hemostat is comprised of oxidized regenerated cellulose, the base component in all of its Surgicel products. The powdered solution comes with an applicator and is designed to penetrate through oozing blood and form clots that stay intact even when the surgical field is irrigated, Ethicon said.
“This new and innovative approach to applying ORC, combined with the proven tr...
Source: Mass Device - June 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Surgical Ethicon Johnson & Johnson Source Type: news
Baxter launches next-gen Floseal, Tisseel hemostatic agents
Baxter (NYSE:BAX) today launched next-gen versions of its Floseal and Tisseel hemostatic products, with improved applicability and designs.
The Deerfield, Ill.-based company launched the Floseal full sterile preparation system, designed to be prepared by a single person with fewer steps than previous versions. The newly launched hemostatic has the same clearances as prior versions, the company added.
“Baxter is committed to introducing innovative products designed to improve patient safety and ease of use. We are excited to bring customer-inspired enhancements to our leading hemostat and sealant portfolio that surge...
Source: Mass Device - April 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Baxter Source Type: news
