Teleflex

Teleflex (NYSE:TFX) posted second-quarter results today that missed the revenue consensus on Wall Street and cut its outlook for the rest of the year.

Shares in TFX were down 10.40% to $238.80 apiece in mid-morning trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%.

The Wayne, Pennsylvania-based company reported profits of $105.5 million, or $2.23 per share, on sales of $704.5 million for the three months ended June 26, for a bottom-line growth of 26.7% on sales loss of 1.26% compared with Q2 2021.

Adjusted to exclude one-time items, earnings per share were $3.39, 85¢ ahead of The Street, where analysts were looking for sales of $719.5 million.

Teleflex is lowering its GAAP EPS for the fiscal year and is reducing in revenue growth guidance to a range of 3.25% to 4.25%. It also expects a year-over-year headwind from the initial phase of its respiratory divestiture completed …

[Image from Teleflex]Teleflex (NYSE:TFX) announced today that it enrolled the first patient in a clinical study of its Manta vascular closure device.

In the study, Wayne, Pennsylvania-based Teleflex intends to demonstrate the safety of Manta ultrasound-guided closure without dependence on the pre-procedural depth locator measurements.

According to a news release, the study will enroll up to 150 patients across up to 15 investigational sites in the U.S. and Canada who are undergoing elective TAVR procedures with planned percutaneous femoral arterial access.

The Manta Ultra study is a prospective, multi-center, single-arm trial with a primary safety endpoint of any large bore access-site related Valve Academic Research Consortium-2 (VARC-2) Major Vascular Complication within 30 days. Teleflex said the occurrence of access site complications is associated with higher rates of morbidity and mortality and increased costs associated with prolonged length of stay.…

Teleflex (NYSE:TFX) today announced it received National Medical Products Administration (NMPA) approval for its UroLift system in China to treat benign prostatic hyperplasia (BPH).

Wayne, Pennsylvania-based Teleflex designed UroLift as a minimally invasive treatment option for lower urinary tract symptoms due to BPH and is indicated in the U.S. for the treatment of an enlarged prostate up to 100cc in men 45 years or older. The approval in China indicates the device for the improvement of symptoms due to urinary outflow obstruction secondary to BPH in men 50 years of age or older, according to the company.

“China is another milestone in our overseas expansion strategy for the UroLift system and provides healthcare practitioners in that region more options for treating men suffering from BPH. As a key component of our durable growth strategy, Teleflex remains committed to making the UroLift system the standard of care in the treatment of BPH globally,” CEO Liam …

Teleflex (NYSE:TFX) today announced its Manta vascular closure device received Health Canada approval.

Wayne, Pennsylvania-based Teleflex designed the Manta biomechanics vascular closure device for large bore femoral arterial access site closure.

“Our team has been working diligently to obtain this approval and were confident that Health Canada would recognize the benefits of the Manta device,” said Scott Holstine, president and GM of Teleflex’s interventional business unit. “We have had great success with the Manta Device since the launch of the product in 2016 with over 100,000 patients treated worldwide. Our team is thrilled that this milestone allows us to now offer this innovative solution to patients in Canada and further fulfill this significant and previously unmet clinical need in the structural heart and endovascular space.”

The device comes in 14 Fr and 18 Fr sizes to reduce time to hemostasis following the use of 10-20 Fr devices or she…

Teleflex (NYSE:TFX) shares were up before hours today on first-quarter results that came in ahead of the consensus forecast.

The (LOCATION)-based company posted profits of $77.1 million, or $1.63 per share, on sales of $641.7 million for the three months ended March 27, 2022, for a 3% bottom-line gain on sales growth of 1.2%.

Adjusted to exclude one-time items, earnings per share were $2.88, 13¢ ahead of Wall Street, where analysts were looking for sales of $634 million.

“Teleflex delivered solid first-quarter results reflecting strong execution, the benefits of our diversified product portfolio, and the dedication of our global team to serving our customers,” Teleflex Chair, President and CEO Liam Kelly said in a news release. “COVID-19 cases trended down throughout the first quarter, and the number of elective surgical procedures increased. Although Teleflex continues to monitor inflationary and supply chain pressures, we believe that the c…

Teleflex (NYSE:TFX) announced today that it launched its UroLift system for treating benign prostatic hyperplasia (BPH) in Japan.

Wayne, Pennsylvania-based Teleflex made the UroLift system for BPH or enlarged prostate available for purchase immediately, having recently received reimbursements approval from the Central Social Insurance Medical Council of Japan (Chuikyo).

The company designed UroLift as a minimally invasive approach that can be performed as a same-day outpatient procedure, providing rapid symptom relief for men with BPH with quick recovery time.

“As we execute on our overseas expansion strategy for the UroLift system, Japan represents an important milestone in our progress,” Teleflex Chair, President and CEO Liam Kelly said in a news release. “The UroLift system offers clinical benefits in the minimally invasive treatment of BPH. Our commercialization in Japan marks another step in our goal to make this novel therapy more broad…

Teleflex (NYSE:TFX) today announced that it received FDA clearance for expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous coronary interventions (CTO PCI).

Devices that are included in the expanded indication are the Teleflex GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheters, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire and R350 guidewire.

Get the full story on our sister site, Medical Tubing + Extrusion.

Teleflex (NYSE:TFX) announced that it initiated a worldwide recall of its Arrow-Trerotola over-the-wire PTD (percutaneous thrombolytic device) kit.

Wayne, Pennsylvania-based Teleflex designed the Arrow-Trerotola (PTD) catheter in conjunction with the Arrow rotator drive unit to allow for the mechanical declotting of the native arterio-venous (AV) fistulae and synthetic dialysis graft.

The company initiated the recall through a voluntary field safety corrective action on Sept. 20, 2021, after receiving reports indicating that the PTD’s inner lumen (orange) detached from the device basket, according to a news release. If the orange inner lumen detaches from the basket, consequences depend upon whether and where the fractured dip component embolizes.

In most cases, Teleflex said, the embolization is local to the treatment target site and allows retrieval with an additional intervention and the consequent delay of therapy, but in some cases, embolizati…