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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Teleflex launches two new PICC insertion devices

Teleflex (NYSE:TFX) + today announced it launched two new devices to enhance PICC insertion procedures and reduce complications.

The company launched the Arrow VPS Rhythm DLX device and the NaviCurve stylet, both of which Teleflex designed to work together to give vascular access specialists more efficient and predictable PICC placement.

VPS Rhythm DLX gives physicians real-time catheter tip location information using the patient’s cardiac electrical activity. The device is available with an optional integrated ultrasound featuring a catheter-to-vessel ratio tool that promotes standardization in vessel measurement. It can work with the Arrow PICC preloaded with the NaviCurve stylet for tip navigation/location technologies.

According to the company, VPS Rhythm DLX with TipTracker technology eliminates the need for a confirmatory x-ray and helps clinicians insert seamlessly through ultrasound vessel assessme…

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Teleflex announces new positive research for UroLift system

The UroLift system. [Image from the Teleflex website]Teleflex (NYSE:TFX) today announced new research from multiple studies supporting the prostatic urethral lift (PUL) procedure with its UroLift system.

Wayne, Pennsylvania-based Teleflex designed UroLift to treat men with benign prostatic hyperplasia (BPH). It presented data at the 38th Annual European Association of Urology (EAU) Congress in Milan, Italy.

The company said in a news release that its study results demonstrate the benefits of early intervention. This comes through durability, symptom improvement and sexual function associated with the UroLift system, Teleflex said.

“These important new analyses show that, whether compared to other interventions or medication, the UroLift System offers unique benefits that make it the treatment of choice for many men searching for long-term relief of burdensome BPH symptoms,” said Jacqueline Welch, VP, global clinical and scientific operations…

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Teleflex performance was mixed in Q4

Teleflex (NYSE:TFX) today reported fourth-quarter results that beat the Wall Street consensus on earnings but missed on revenue.

Analysts initially described its revenue growth guidance for 2023 as disappointing.

The Wayne, Pennsylvania–based maker of critical care and surgical products earned $78.6 million, or $1.66 per share, off $758.0 million for the quarter that ended Dec. 31, 2022. The bottom line was down nearly 39% compared with Q4 2021. Revenue declined slightly.

Adjusted to exclude one-time items, Telflex had an EPS of $3.52. The result was 8¢ ahead of the The Street, where analysts expected EPS of $3.44 and revenue of $760.35 million.

“Our business showed continued resilience in the fourth quarter with a sequential improvement in constant currency revenue growth and margin expansion,” Teleflex CEO Liam Kelly said in a news release.

“In the quarter, we maintained healthy margins, and advanced our capital allocati…

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Teleflex warns on some intra-aortic balloon pumps

Teleflex (NYSE:TFX) subsidiary Arrow initiated a voluntary field safety corrective action for some intra-aortic balloon pump devices.

According to a safety notice issued in Europe, the devices have a potential issue around short battery run times. The devices can be powered by either an AC power source or battery power. As of Oct. 11, 2022, Teleflex received no reports of patient injuries or deaths related to the issue.

Affected devices include the Arrow AutoCAT 2 and Arrow AC3 Optimus pumps.

The affected pumps have an expected duration after a full charge of 90 minutes. However, some users reported short battery run times that included loss of power during use.

Additionally, the device design includes alarms. Those alert users of 20, 10 and 5 minutes of battery life remaining. In the past two years, Teleflex received one complaint of the unit shutting off without the alarms going off. It received 13 complaints reporting missing alarms where users…

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Teleflex announces another round of restructuring

Teleflex (NYSE:TFX) plans another round of restructuring — including manufacturing offshoring — to better position itself for long-term growth.

In a Form 8-K filed with the SEC today, the Wayne, Pennsylvania–based maker of critical care and surgical products said it expects to incur $31 million to $40 million in restructuring costs through 2023. About $18 million to $22 million of that amount involves termination benefits.

Teleflex did not specify how many workers it plans to lay off. It listed 14,000 employees in its most recent annual report.

Company officials said in the filing that they developed the restructuring plan to offset increasing costs and inflationary pressures in the healthcare industry.

The plan primarily involves relocating certain manufacturing operations to existing lower-cost locations, according to the company.  In addition, Teleflex plans to streamline various business functions across the organization.

Teleflex expec…

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Teleflex has a serious breathing circuit bacterial filters recall

The FDA this week said the Teleflex (NYSE:TFX) recall of some Gibeck Iso-Gard bacterial and viral filters is a Class I recall, the most serious kind.

Teleflex is recalling several types of the Iso-Gard Filter S after receiving reports that the filter may split or become detached from breathing systems.

Iso-Gard Filter S filters are used as breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in intensive care units and operating rooms. They protect the equipment and the patients from potential airborne contaminants.

If the filter splits or detaches during use, the filter may not work properly and could cause a patient to receive an insufficient supply of air, with patient oxygen levels potentially dropping below safe levels. There is also a risk of cross-contamination.

The FDA said in a recall notice that using these devices could result in serious injury or death. So far, there have been 36 complain…

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Teleflex profits drop 48% in Q3

Teleflex (NYSE:TFX) today posted third-quarter results that beat the earnings consensus on Wall Street but missed revenue estimates.

The Wayne, Pennsylvania–based maker of critical care and surgical products reported profits of $101.9 million, or $2.16 per share, on sales of $686.8 million for the three months ended Sept. 27. The results represented a bottom-line slide of 48.8% and top-line cut of 1.92% compared with Q3 2021.

Adjusted to exclude one-time items, earnings per share were $3.27, 16¢ ahead of The Street, where analysts were looking for sales of $691.48 million.

More on Teleflex’s Q3 earnings report

“Our third quarter financial results reflect revenue contributions from our high-growth portfolio and durable core,” President and CEO Liam Kelly said in a news release. “We continue to execute on our long-term strategic objectives, deploying capital to purchase Standard Bariatrics. The [$170 million] acquisition of Standard…

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Teleflex completes $170M Standard Bariatrics acquisition

Teleflex (NYSE:TFX) announced today that it completed its acquisition of Standard Bariatrics and its powered stapling technology.

Wayne, Pennsylvania-based Teleflex announced its acquisition of Cincinnati, Ohio-based Standard Bariatrics last month.

The definitive agreement included a $170 million price for the bariatric surgery technology developer at closing. Teleflex could pay up to an additional $130 million upon the achievement of certain commercial milestones.

According to a news release, the acquisition won’t contribute meaningfully to Teleflex’s 2022 revenue. The company expects it to be approximately 10¢ dilutive to adjusted earnings per share.

In 2023, Teleflex expects the transaction to contribute between $30 million and $35 million in revenue. Teleflex expects it to be approximately 10¢ to 15¢ dilutive in adjusted EPS. It expects it to be accretive to revenue growth and adjusted EPS thereafter.

Standard Bariatrics des…

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