Category: MENA

MedSource Labs Unveils ClearSafe Comfort® and TrueSafe Comfort® Blood Control Safety IV Catheters to protect medical staff and patients

[Minneapolis, Minnesota, Chanhassen], May 14, 2024 (GLOBE NEWSWIRE) — MedSource Labs moves the needle in the peripheral safety IV market with the announcement of ClearSafe Comfort and TrueSafe Comfort Blood Control IV Catheters with groundbreaking active blood control check valve technology.

ClearSafe Comfort and TrueSafe Comfort Blood Control IV catheters provide significant benefits over other IV catheters.

1. Safety: A new blood control device to significantly reduce the risk of exposure to bloodborne pathogens to the caregiver and patient.
2. Precision: A translucent flashback chamber confirms vessel entry and ensures accuracy.
3. Front-line functionality: The ergonomic design and non-slip grip ensure easy handling for healthcare workers.

“Healthcare professionals subject themselves to the risks associated with needlestick injuries and exposure to bloodborne pathogens every time they access a vein,” said Dave Kunelius, President at MedSource Labs. “ClearSafe Comfort and TrueSafe Comfort Blood Control Safety IV Catheters have been engineered to minimize these risks, allowing medical staff to better serve their patients without distraction or worry.”

These devices conform to the U.S. Needlestick Safety and Prevention Act.

MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. The ClearSafe Comfort and TrueSafe Comfort Blood Control Safety IV Catheters are part of MedSource Labs’ high-performing IV catheter lines focused on caring for the caregiver. See the TrueSafe Animations and ClearSafe Animations for a detailed view.

“Quality has always been a key component of our IV catheter products, and the ClearSafe Comfort and TrueSafe Comfort blood control products raise the bar for medical staff safety and patient care,” said Kunelius.

MedSource Labs is ISO 13485:2016 certified for quality management in medical device manufacturing, registered with the FDA, and the blood control catheters are 510(k) Cleared Products.

ABOUT MEDSOURCE LABS

MedSource Labs is a leading provider of quality medical products, specializing in high-quality products, equipment and innovative class II medical product development. For over two decades, MedSource Labs has been a trusted provider of quality medical products at a superb value. Recently, MedSource Labs has expanded into new markets and grown its international services and offerings, including a focus on the EMERGE product imagine/design/build process.

Attachment

• Press Release – MedSource Labs Blood Control Product Launch

Jeremy Belloit
MedSource Labs
(952) 472-0131
[email protected]

GlobeNewswire Distribution ID 9116905

King Faisal Specialist Hospital and Research Centre Welcomes New Deputy CEO Amid Strategic Transformations

King Faisal Specialist Hospital and Research Centre Welcomes New Deputy CEO Amid Strategic Transformations

RIYADH, Saudi Arabia, May 13, 2024 (GLOBE NEWSWIRE) — King Faisal Specialist Hospital and Research Centre (KFSH&RC) has recently welcomed Dr. Björn Zoéga as its Deputy CEO, an appointment that underscores its commitment to promoting and fostering healthcare excellence. Dr. Zoéga, renowned for his extensive experience in healthcare management and policy, joins a dedicated team as the hospital continues to drive key strategic initiatives.

KFSH&RC, a leader in medical research and clinical services, continues to attract global expertise to bolster its vision of healthcare excellence. With Dr. Zoéga’s involvement, the hospital is advancing a digital transformation strategy designed to improve operational efficiency and enhance patient care. His expertise in fostering international collaborations, evidenced by his former role as president of the European University Hospital Alliance (EUHA) and through initiatives like JOIN4ATMP aimed at advancing access to innovative therapies, further aligns KFSH&RC’s services with global healthcare trends.

Key projects at KFSH&RC include the deployment of advanced digital technologies to streamline the patient care process, the adoption of innovative care models, and the upgrading of facility amenities. These strategic efforts aim to improve access to medical services and facilitate better communication, reflecting KFSH&RC’s dedication to setting new standards in healthcare.

Dr. Zoéga’s previous contributions at Karolinska University Hospital, which is ranked the second best in Europe and seventh globally by Newsweek’s 2024 World’s Best Hospitals, where he nurtured a culture of continuous learning and collaboration among healthcare professionals, align well with KFSH&RC’s objectives. His role in fostering programs like EUCARE and facilitating the Europe-wide exchange of intensive care nurses during crises has significantly enhanced staff development and supported his previous hospital’s goal of attracting top talent—a principle mirrored in KFSH&RC’s transformation journey. With Dr. Zoéga contributing to leadership, KFSH&RC is poised to further its role as a pivotal player in shaping the future of healthcare in Saudi Arabia.

About King Faisal Specialist Hospital and Research Centre:

King Faisal Specialist Hospital & Research Centre stands among the global leaders in providing specialized healthcare, driving innovation, and serving as an advanced medical research and education hub. Through strategic partnerships with prominent local, regional, and international institutions, the hospital is dedicated to advancing medical technologies and elevating healthcare standards worldwide.

The hospital has secured its position as the leading brand in the healthcare sector across the Kingdom and the Middle East, marking its second consecutive year as the most valuable healthcare brand. It ranks 9th within the Kingdom and 28th in the Middle East. The hospital distinguishes itself as the sole hospital globally to break into the top 10 brands in its country, as highlighted in two reports by “Brand Finance” on the 50 most valuable brands in Saudi Arabia and the 150 most valuable brands in the Middle East in 2024.

Due to the transformation programs and the Kingdom’s Vision 2030, launched by His Royal Highness the Crown Prince and Prime Minister – may God protect him – to enhance the Kingdom’s leadership in the global healthcare sector, KFSH&RC has emerged as a leading Academic Medical Centre in the Middle East and Africa. It maintained its 20th rank globally for the second consecutive year in 2024, according to “Brand Finance.” Additionally, it has been ranked among the top 250 hospitals globally in 2024 by the American magazine “Newsweek.”

For further information, please contact:

Mr. Essam AlZahrani, Acting Head of Media Affairs, 0555254429

Mr. Abdullah Alown, Media Coordination Officer, 0556294232

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/83d04605-9a75-41cb-8947-81c858209621

GlobeNewswire Distribution ID 9116335

Milestone Highlights Transformative Symptom Management for Patients Living with Heart Failure

Marlton, NJ, May 13, 2024 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today that it has reached a worldwide milestone by surpassing 10,000 patients having received the Optimizer^® system for the treatment of moderate HF. This milestone highlights the benefit and importance of this therapy in helping patients live a full life with HF.

“I noticed positive changes since the procedure, such as not feeling cold or numb, I could walk every day and everywhere, did my regular chores and shopping, and shared activities like swimming with my daughter,” said Tracey, who received her CCM^® device in 2023. “I’m no longer huffing, puffing, or gasping for air,” said Joe, another HF patient who received his CCM device in 2022. “I’m reborn ─ a whole new person ─ no longer incapacitated. My life has changed so much that we’re considering taking a trip. And my wife is ecstatic because I have my life back, and we have ours again.”

“We are deeply motivated by the patients who benefit from CCM therapy. Their progress inspires us to continuously enhance our technology, aiming to improve the lives of those suffering from heart failure,” said David Prutchi, Chief Technology Officer for Impulse Dynamics, who has worked on the development of CCM therapy since its inception.

David had the opportunity to meet one of these patients, Raynita, who was implanted with an Optimizer device this year. Raynita saw immediate improvement after starting CCM therapy and gave the following remarks on the experience: “I feel like a different person. I can do things I haven’t done in years. I am attending my granddaughter’s college graduation!”

CCM is available in 44 countries, and the technology has continued to advance, based on the needs of patients and physicians. The latest generation of the proprietary CCM technology is the Optimizer Smart Mini, which offers a rechargeable battery with 20-year battery life and a smaller size designed to make the implant procedure faster and easier for patients and physicians.

“We are committed to ongoing innovation in this important therapy that has such a clear clinical need around the world,” said Jason Spees, CEO of Impulse Dynamics. “We are also getting closer to significantly impacting the implantable cardioverter defibrillator (ICD) market with successful enrollment in our INTEGRA-D clinical trial on the CCM-D^® HF System, which is the first-of-its-kind technology, combining the lifesaving benefits of an ICD with HF symptom relief through CCM therapy in one device.”

The patients statements in this Press Release represent the testimonials of their individual outcomes and may not be typical for all patients.

About the Optimizer and CCM Therapy 

The Optimizer Smart Mini system delivers CCM therapy — the company’s proprietary technology — to the heart, providing an important treatment option for the millions of patients suffering from heart failure. CCM therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body.[1] CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III HF patients who remain symptomatic despite guideline directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

CCM is the brand name for cardiac contractility modulation—the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which appeared in more than 100 articles from leading medical journals.

About Impulse Dynamics

Impulse Dynamics is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer technology platform to improve quality of life in HF patients. CCM therapy is delivered through the Optimizer system, which includes an implantable pulse generator (IPG) implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 10,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, X (formerly Twitter), and Facebook.

Forward-looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.

[1] European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202

Attachment

• David and Raynita

Scott Way, Executive Vice President, General Counsel
Impulse Dynamics
856-434-7906
[email protected]

Rohan More, Global Vice President, Marketing
Impulse Dynamics
856-642-9933
[email protected]

GlobeNewswire Distribution ID 9116301

KFSH&RC Strives to Pioneer in Maximizing Healthcare Spending Value