Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters

Teleflex (NYSE: TFX) + announced today that it released its Arrow ErgoPack complete kits with hemodialysis and larbe bore catheters in the U.S.

Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs.

Get the full story at our sister site, Medical Tubing & Extrusion.

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Teleflex posts Street-beating Q2, raises 2023 sales guidance

Teleflex (NYSE: TFX) + shares fell this morning despite strong second-quarter results and an increased full-year guidance.

Shares of TFX dipped 2.8% at $241.75 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.8%.

The Wayne, Pennsylvania-based company posted profits of $111.3 million in the quarter. That amounts to $2.23 per share on sales of $743.3 million for the three months ended July 2, 2023.

Teleflex recorded a 5.5% bottom-line gain on sales growth of 5.5%.

Adjusted to exclude one-time items, earnings per share came in 20¢ ahead of Wall Street expectations of $3.21. Sales topped analysts’ forecasts too as they projected $729.9 million in revenue.

Teleflex’s OEM business reported the strongest growth, improving by 20.2% year-over-year. Vascular Access (6%), Interventional …

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Teleflex wins expanded FDA indication for QuikClot Control+ hemostatic device

Teleflex (NYSE: TFX) + announced today that the FDA expanded the indication for its QuikClot Control+ device.

The expanded indication for the hemostatic device includes mild and moderate bleeding in cardiac surgical procedures. It also includes bone surface bleeding following a sternotomy. Indication expansion allows clinicians to use QuikClot Control+ to control all bleeding in cardiac surgical procedures. Teleflex says this enables device utilization across a wider patient population and breadth of surgical procedures.

Wayne, Pennsylvania-based Teleflex bought QuikClot Control+ as part of its $500 million acquisition of Z-Medica in 2020. The device also received expanded uses to include patients on anticoagulation/antiplatelet medication. It can treat patients with or without autotransfusion (blood salvage) equipment and be used with or without cardiopulmonary bypass sys…

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Teleflex to acquire Palette Life Sciences to boost its urology portfolio

Teleflex (NYSE: TFX) + announced today that it entered into a definitive agreement to acquire Palette Life Sciences.

The deal to acquire the privately-held urology technology developer includes an upfront cash payment of $600 million at closing. It also includes up to an additional $50 million upon the achievement of certain commercial milestones.

Wayne, Pennsylvania-based Teleflex said in a news release that it expects to complete the acquisition in the fourth quarter of 2023. The company believes Palette’s offerings expand its interventional urology portfolio, which includes the UroLift system.

Palette develops a non-animalized stabilized hyaluronic acid (NASHA) spacer and tissue bulking products. The company estimates standalone revenues of approximately $56 million in 2023. Assuming a Dec. 1, 2023, closing, Teleflex does not expect the acquisition to significantly impact its revenue for the year.

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Teleflex completes enrollment in percutaneous coronary intervention study

Teleflex (NYSE: TFX) + announced today that it completed patient enrollment in its prospective multicenter Ringer PTCA study.

Ringer PTCA is one of two clinical studies evaluating Teleflex’s novel Ringer perfusion balloon catheter. The trial enrolled patients across seven leading complex percutaneous coronary intervention (PCI) centers in the U.S. and Canada. Dr. Kathleen Kearney of the University of Washington leads the trial.

Kearney said in a news release that Ringer’s availability “is much anticipated by the interventional cardiology community.” She added that completed enrollment in the trial marks “a big step” toward that milestone.

Wayne, Pennsylvania-based Teleflex said the study employed Ringer in selected coronary intervention patients who could benefit from continued perfusion during coronary balloon inflations.

Parallel to Ringer PTCA, Teleflex …

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Telefex recall of Arrow catheter system in Class I

The FDA today designated Teleflex’s recall of its Arrow Endurance extended dwell peripheral catheter system as Class I, the most serious type of medical device recall.

The recall involved 262,016 devices distributed from October 26, 2018, to May 10, 2023, according to the FDA.

Teleflex and its Arrow International subsidiary have reported 83 complaints related to this issue. There are reports of 18 injuries but no deaths.

The Endurance system provides short-term access to a person’s peripheral vascular system, enabling health providers to sample blood, monitor blood pressure, or administer fluids, blood, and blood products.

Teleflex initiated a recall on May 19 after receiving reports of catheter separation or leakage. If the catheter separates while in a blood vessel, the catheter fragments could be left in the bloodstream and may migrate to other places in the body. The situation could cause a person to experience a blockage of blood …

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Teleflex recalls some of its Rüsch endotracheal tubes

Teleflex this week announced a global recall of affected batches of its Rüsch endotracheal tube products.

The Wayne, Pennsylvania-based company is recalling certain devices due to reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. There is a possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation.

Initial investigations have identified that the disconnection results from the intermittent cross-contamination of the 15mm connector with trace amounts of silicone oil. Although this does increase the lubricity of the connection, this does not present additional clinical risks, according to the company.

Where patients are undergoing mechanical ventilation in either the operating room or critical care settings, the ventilation devices to which the affected devices are connected are designed to alarm immediate…

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Teleflex partners with Insighters Medical to distribute video laryngoscope

Teleflex (NYSE: TFX) + today announced a partnership with Shenzhen Insighters Medical Technology Co., even as its stock took a hit from an analyst downgrade.

The partnership makes Teleflex the exclusive U.S. distributor of the Insighters video laryngoscope system. Insighters designed the system to inspect the upper glottic airway and facilitate endotracheal intubation. It features interchangeable accessories and components to support a variety of intubation scenarios. The system also records real-time, high-resolution images and video.

The news comes on the same day that Needham & Co. downgraded its rating of TFX shares to Hold from a previous Buy. Senior research analyst Mike Matson wrote that Needham research found that urologists are reducing their use of UroLift due to its retreatment rates, reimbursement cuts, and increasing use of competing procedures. Matson added that Teleflex’s Manta large-bore closu…

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FDA clears Teleflex’s Wattson temporary pacing guidewire

Teleflex (NYSE:TFX) announced today that it received FDA clearance for its Wattson temporary pacing guidewire for use in heart procedures.

Wayne, Pennsylvania-based Teleflex says it’s the first commercially available bipolar temporary pacing guidewire designed specifically for use during TAVR and BAV. The company plans to feature Wattson at TVT: The Structural Heart Summit, June 7-10 in Phoenix.

Wattson features dual functionality, supporting both valve delivery and ventricular bipolar pacing. It offers a procedural alternative to help avoid a variety of complications, steps and costs associated with right ventricular pacing.

Teleflex said it designed Wattson with a flexible distal pigtail shape and multiple electrodes for bipolar capabilities. It helps reduce the risk of ventricular perforation while providing confidence in capture during rapid pacing.

The company intends to launch the Wattson temporary pacing guidewire in a limited market …

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Teleflex Arrow EZ-IO needle cleared for use in MRI

The Arrow EZ-IO system. [Image from Teleflex]Teleflex (NYSE:TFX) announced today that it received FDA 510(k) clearance for its Arrow EZ-IO needle for MR conditional labeling.

Wayne, Pennsylvania-based Teleflex said the regulatory nod makes the needle the first and only intraosseous needle with 510(k) clearance.

The EZ-IO needle represents a critical component of Teleflex’s Arrow EZ-IO intraosseous vascular access system. It features a patented diamond tip for fast, precise and steady insertion. The system can be used when intravenous access is difficult or impossible to obtain in emergent, urgent or medically necessary cases.

New labeling enables the clinician to care for patients requiring MRI scans without interrupting the established vascular access site. Michelle Fox, Teleflex VP and chief medical officer, said it provides an additional vascular access option for those requiring MRI.

“Teleflex continues to innovate on behalf of clinicians w…

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Teleflex signs purchasing agreements with Premier

Teleflex today announced it was awarded two group purchasing agreements with Premier, effective July 1.

The new agreements allow Premier members, at their discretion, to use special pricing and terms pre-negotiated by Premier for Teleflex’s central venous and arterial vascular access products.

Premier also awarded Teleflex a national agreement for hemodynamic monitoring products and accessories, a national agreement for central venous access, a sole source for AscenDrive central venous access and a sole source for Surpass central venous access.

“Teleflex strives to deliver vascular access products that are designed to benefit both clinicians and patients, while helping to protect against vascular access-related complications like infection and thrombosis,” said Lisa Kudlacz, president and general manager of Teleflex Vascular. “As the market leader in both Central Venous Catheters and Arterial Access Catheters1, we are pleased to continue to support…

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Teleflex vascular access division drives sales growth in Q1, despite share price drop

Teleflex (NYSE: TFX) + today announced first-quarter results that beat the overall consensus on Wall Street.

The Wayne, Pennsylvania-based company reported profits of $78.7 million, or $1.62 per share, on sales of $710.9 million for the three months ended April 2, for a bottom-line loss of 0.5% and sales growth of 10.79% compared to Q1 2022.

Adjusted to exclude one-time items, earnings per share were $3.09, 12¢ ahead of The Street, where analysts were looking for sales of $686.86 million.

“We had a strong start to 2023 as our broad business momentum exiting last year continued into the first quarter” Teleflex CEO and President Liam Kelly said in a news release. “In the quarter, we drove revenue growth in all global product categories and expanded our overall margins year-over-year. We also executed against our new product launch objectives and continued our integration of Standard Bariatrics. O…

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