Southlake, TX, Dec. 05, 2023 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that it has received confirmation from the […]
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Teleflex Awarded Peripheral Access Agreement with Premier, Inc.
WAYNE, Pa., Dec. 05, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced it was awarded the Peripheral Access purchasing agreement with Premier, Inc. Effective December 1st, 2023, the new agreement allows Premier members, at their discretion, to take advantage of special […]
VESTECK, invited to present at the 16th Annual Greenberg Stent Summit, Boston, MA
WEST CHESTER, Pa., Dec. 4, 2023 /PRNewswire/ — The VESTECK, Inc. Chief Technology Officer, invited to present the “SUTURE-TIGHT”™ technology at the 16th Annual Greenberg Stent Summit, sponsored by Mass General Brigham.
Stent Summit organizers requested Ted Wulfman, VESTECK, Inc. Chief Technology Officer, join in and stimulate the discussion on “There’s more to aneurysm treatment than the use of an endograft. What are the roles of adjunctive treatments in aneurysm treatment?” Tuesday 12/5/2023 10:56-11:17AM.
The 16th Greenberg Stent Summit brings together clinicians, members of the FDA and industry notables to create two and a half days of lively discussion on advances in aortic disease repair.
Mr. Wulfman commented, “I am honored to say the least. To receive an invitation to participate at such a prestigious conference as the Greenberg Stent Summit is a true honor. Two weeks ago, Prof. Krievins presented “SUTURE-TIGHT” at the iconic Veith meeting and now we are contributing to the conversation at the Boston Stent Summit. Very exciting stuff.”
“The positive momentum continues at VESTECK. We appreciate the podium presence. 9 clinical cases successfully completed. Patients are doing well. 3 new patents have been filed. We are headed to Australia, conducting clinical cases with Professors Ramon Varcoe and Andrew Holden, helping more moms, dads, brothers and sisters,” said VESTECK CEO, Joe Rafferty.
About VESTECK, Inc. (WWW.VESTECK.com) is a clinical stage medical device company focused on bringing a platform technology to the aortic repair, structural heart, peripheral vascular markets. The “SUTURE-TIGHT”™ catheter comes preloaded with 4 pair of nitinol sutures, it secures EVAR/TEVAR grafts to the aorta on initial implant or during repair procedures. “SUTURE-TIGHT”™ brings a simple, easy to use technology to physicians, patients and payors.
VESTECK is raising a $16M Series B round to support a clinical trial for FDA 510K clearance.
The VESTECK, Inc. “SUTURE-TIGHT”™ is not commercially available in the USA or OUS.
MEDIA CONTACTS: VESTECK CEO, Joe Rafferty, [email protected]
Please note that this document reflects statements that may constitute forward-looking statements and projections that are subject to risks and uncertainties, including information about possible or assumed future events, results of economic conditions and VESTECK’s business, results of operations, plans and objectives. These statements are based on management’s beliefs, assumptions and expectations of VESTECK’s future performance, taking into account information currently available to it. You should not place undue reliance on such statements, as new risks and uncertainties may arise and it is not possible for management to predict those events or how they may affect VESTECK, Inc.
SOURCE VESTECK, Inc.
Merit Medical Announces Proposed Private Placement of $550 Million of Convertible Senior Notes
SOUTH JORDAN, Utah, Dec. 04, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (Nasdaq: MMSI) (“Merit”), a leading global manufacturer and marketer of healthcare technology, announced today that it intends to offer, subject to market conditions and other factors, $550.0 million aggregate principal amount of Convertible Senior Notes due 2029 (the […]
Roivios® announces final patient enrollment in feasibility trial for JuxtaFlow® Renal Assist Device (RAD)
ROSWELL, Ga., Dec. 4, 2023 /PRNewswire/ — Roivios Ltd., a medical device company pioneering a revolutionary treatment to reduce poor surgical outcomes associated with Acute Kidney Injury (AKI), today announces that the final patient has been enrolled in the BIPASS-AKI study for the JuxtaFlow Renal Assist Device (RAD). The Institute of Cardiovascular Diseases, Sremska Kamenica in Serbia was the highest enrolling site, led by principal investigator Prof Dr Milovan Petrovic, cardiac surgeon Prof Dr Lazar Velicki and urologist Dr Dimitrije Jeremic. Additional study sites include The American Heart Hospital in Bielsko Biala, Poland and The Institute for Cardiovascular Diseases Dedinje, Serbia.
“When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment,” said Prof. Petrovic. “We frequently perform cardiac surgery on patients with renal impairment and they are among our most complicated cases, so we are proud to have enrolled several patients into this study to contribute insights into this novel therapy in advance of its pivotal trial.”
Cardiac surgery-associated AKI (CSA-AKI) occurs in up to 73% of patients who have pre-existing renal insufficiency documented as part of their standard pre-surgical workup1. This type of AKI then impacts a patient’s ability to recover from surgery, leading to a longer and more costly hospital stay, a higher risk of morbidity and mortality, and a more frequent need for chronic dialysis treatment2-5. The JuxtaFlow RAD is used in the hospital setting and is designed to enable the kidneys to function optimally and thereby improve overall patient outcomes.
“The mission of Roivios is to give clinicians the tools to protect, preserve and improve kidney function. Cardiac surgery is a major stress on the kidneys, and today these patients have few options. Our team is inspired to design a system that would assist critical renal function during times of acute stress, employing an innovative solution that enhances the kidneys’ own natural function to support recovery.”, said John Erbey, PhD, Chief Executive Officer of Roivios. “We are incredibly excited to have completed the first step in providing this novel therapy for at-risk patients and serve as the bridge to their successful recovery. We look forward to sharing this BIPASS-AKI data shortly and then continuing to partner with hospitals, surgeons, and critical care teams around the world who share our vision for reducing this all-too-frequent adverse event of surgery.”
The BIPASS-AKI feasibility trial was being conducted pursuant to the regulations of both ALIMS in Serbia and URPL in Poland. Ten patients were enrolled between September and December.
The JuxtaFlow RAD is not commercially available in any geography. The system is limited by United States law to Investigational Use Only and is not available for sale in the United States.
For more information about the JuxtaFlow RAD system, please visit www.roivios.comFor more information about BIPASS-AKI, see https://clinicaltrials.gov/study/NCT05990660
ContactJohn Erbey, PhD, Chief Executive Officer[email protected]
Shen W, Aguilar R, Montero AR, et al. Acute Kidney Injury and In-Hospital Mortality after Coronary Artery Bypass Graft versus Percutaneous Coronary Intervention: A Nationwide Study. Am J Nephrol. 2017;45(3):217-225.
Bowdish ME, D’Agostino RS, Thourani VH, et al. STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research. Ann Thorac Surg. 2021;111(6):1770-1780.
Robert AM, Kramer RS, Dacey LJ, et al. Cardiac surgery-associated acute kidney injury: a comparison of two consensus criteria. Ann Thorac Surg. 2010;90(6):1939-1943.
Palomba H, de Castro I, Neto AL, Lage S, Yu L. Acute kidney injury prediction following elective cardiac surgery: AKICS Score. Kidney Int. 2007;72(5):624-631.
Brown JR, Kramer RS, Coca SG, Parikh CR. Duration of acute kidney injury impacts long-term survival after cardiac surgery. Ann Thorac Surg. 2010;90(4):1142-1148.
About Roivios
Roivios® is a medical device company pioneering a novel renal assist device designed to reduce or eliminate acute kidney injury (AKI) in patients who are at elevated risk.
Initially focused on meeting an unmet need of cardiac surgery associated-acute kidney injury (CSA-AKI) in the coronary artery bypass and surgical valve population, our pioneering renal assist device has the potential to address a range of poor outcomes.
Our first product, the JuxtaFlow Renal Assist Device, is the world’s first negative pressure renal assist device, featuring a patented catheter and unique energy delivery system.
SOURCE Roivios, ltd
Colibri’s transcatheter aortic valve [TAVR] EU pilot study validates its pre-mounted, pre-packaged, dry tissue, ready-to-use balloon-expanded valve with demonstration of superior hemodynamics
LOUISVILLE, Colo., Dec. 1, 2023 /PRNewswire/ — The initial findings of Colibri Heart Valve’s multicenter high-risk TAVR EU pilot study were presented at PCR London Valves November 20th, 2023. The study was conducted by CERC (Centre Européen de Recherche Cardiovasculaire) as acting CRO (clinical research organization).
Speaking on behalf of the study’s team of investigators, Dr Bernard Chevalier, principal investigator, L’hôpital Privé Jacques Cartier, Massy, France, presented the primary 30-day endpoint results of the trial in the 26 patients, classified at high-risk for surgical aortic valve replacement, who received the Colibri dry tissue TAVR valve utilizing the pre-mounted, pre-packaged delivery system. All patients survived to the initial 30-day milestone. Central core laboratory measurements indicated notably high measures of hemodynamic valve performance, including mean valve area of 2.23 cm2 and mean Doppler index of 0.56 at 30 days.
The report represents major clinical validation of Colibri’s ground-breaking, world’s first TAVR system utilizing a pre-mounted, pre-packaged, dry tissue, ready-to-use balloon-expanded valve and system design that does not involve mounting of the valve prosthesis in the catheterization laboratory. The hemodynamic performance of Colibri’s unique, innovative leaflet design appears to surpass that of predicate balloon-expanded TAVR valves.
Professor David Hildick-Smith, Head of Structural Heart Disease at the University Hospitals Sussex in Brighton, UK, said “The Colibri pre-mounted TAVI system is very straightforward and efficient. It comes preloaded in its packaging – just like a coronary stent does. We can take the system directly from its packaging and implant it in the patient. There is no need for valve crimping, loading, or other technical assistance. Furthermore, and crucially, the valve area obtained is significantly greater than with other valve systems, and this may prove very advantageous in terms of symptom resolution and valve durability.”
Colibri believes these results provide strong validation of its innovative pre-mounted TAVR valve—the first truly ready-to-use valve system that will set a new standard in structural heart technology, and the company now looks forward to launching its FDA feasibility trials.
About Colibri Heart Valve:
Colibri Heart Valve LLC (“Colibri”) is a privately held medical device company that researches and develops novel, patent protected, structural heart technologies. Colibri was formed in 2010 and through its proprietary tissue technology and valve design, Colibri has developed a pre-mounted, pre-crimped, and pre-loaded, Ready-for-Use balloon expandable transcatheter aortic valve implantation (TAVI) system called the “Colibri TAVI System.” The Colibri technology is protected by both trade secrets and issued and pending patent applications with priority claims and content dating back to January 4, 2002. https://www.colibrihv.com
For more information please contact:
Thomas Wolf 303-808-2570.
SOURCE Colibri Heart Valve
Silence Therapeutics Strengthens Executive Leadership Team with Key Appointments
LONDON–(BUSINESS WIRE)–Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the “Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced Curtis Rambaran, MD, previously Silence’s Vice President, Head of Clinical Science, has been promoted to Chief Medical Officer, and Marie […]
Johnson & Johnson MedTech Acquires Laminar, Inc.
NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson MedTech1 today announced the completion of the acquisition2 of Laminar, Inc., a privately-held medical device company focused on eliminating the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib). Johnson & Johnson MedTech acquired Laminar for an upfront payment of $400 million, subject to […]
Procyrion Announces First Patient Enrollments in the DRAIN-HF Pivotal IDE Trial for Aortix™ Percutaneous Mechanical Circulatory Support Technology
Technology to be evaluated in acute decompensated heart failure patients, where current treatment options remain ineffective and lacking HOUSTON, Nov. 30, 2023 /PRNewswire/ — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal…
Next-Generation Microcatheter for Embolic Agent Delivery Cleared by the FDA
PARK CITY, Utah, Nov. 30, 2023 /PRNewswire/ — Transit Scientific, a Utah-based medical device company specializing in innovative solutions for vascular procedures, has announced the FDA clearance of its microcatheter designed for the precise delivery of a broad range of embolic agents….
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