6 drug delivery innovations you need to know

From wearable insulin delivery devices to drug-eluting implants and everything in between, drug delivery innovation never stops.

Vaccines, life-saving therapeutics, vision-correcting drugs and more are being developed and marketed for delivery with all kinds of technologies.

More than a year ago, we compiled a list of eight drug delivery innovations you need to know. With some updates on some of those technologies, plus introductions to others, here are some more impressive developments you should keep an eye on:

1. Needle-free delivery

Vaccines have become a major talking point over the past couple of years amid the COVID-19 pandemic and a number of companies are working on ways to deliver them, as well as other forms of medication, through different avenues.

A major speed bump in vaccine hesitancy can be fear of needles, so the introduction of needle-free drug delivery could make big waves in the space.

Two companies pushing forward with …

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Cook Medical makes next-gen in vitro fertilization incubator available in U.S., Canada

[Image from Cook Medical]Cook Medical announced today that it launched the next-generation MINC+ benchtop incubator in the U.S. and Canada.

Bloomington, Indiana-based Cook Medical designed its MINC+ platform as the latest iteration of the MINC mini incubator benchtop system that has been in in-vitro fertilization (IVF) clinics for more than two decades.

The latest version of MINC includes the DishTrace platform designed to combine functionality through the incubator touchscreen and a PC software program for a wide array of dish-data management tools, according to a news release.

With DishTrace, users can access and log information through the system’s touchscreen, track culture dishes as they are checked in and out of incubator, monitor up to 50 MINC+ incubators and generate and view graphical histories and reports of MINC+ activity, Cook Medical said.

“We listened to user feedback when…

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Cook Medical wins FDA breakthrough designation for Thoraco+ endovascular system

Cook Medical today announced that its Zenith Thoraco+ endovascular system received FDA breakthrough device designation.

Thoraco+ is the company’s next-generation endovascular graft that is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms.

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

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CooperCompanies buys Cook Medical’s reproductive health business for $875M

Cook Medical announced today that it has signed a letter of intent to sell its Reproductive Health business to CooperCompanies.

CooperCompanies (NYSE:COO) plans to pay privately-held Cook Medical $875 million — $675 million at closing, with the remaining $200 million paid in four $50 million annual installments.

The proposed deal is subject to applicable local consultation obligations and regulatory approvals.

For more than 40 years, Cook focused on Reproductive Health. Over the decades, it developed products for obstetrics and gynecology, in vitro fertilization (IVF) and assisted reproductive technology (ART).  The company’s work included developing the first needle specifically for IVF treatments.

“Our history with reproductive health has been full of innovations to help patients fulfill their dreams of having a family,” D.J. Sirota, SVP of Cook Medical’s MedSurg specialty, said in a news release.

“This agreement represents more tha…

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Cook Medical wins FDA breakthrough designation for new drug-eluting stent

Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee.

Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI).

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

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Cook Medical issues voluntary recall for transseptal needles, transseptal needles with catheter

Cook Medical this week announced a global voluntary recall of its Transseptal Needle and Transseptal Needle with catheter.

Bloomington, Indiana-based Cook Medical issued the recall due to complaints of rust on the products. The use of both products could result in increased procedural time and inflammatory reactions, including systemic reactions that could lead to permanent impairment or death, according to the company.

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

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Cook Medical warns on some Flexor Check-Flo introducer sheaths

Cook Medical recently issued a warning letter regarding an issue with its Flexor Check-Flo introducer catheters.

Bloomington, Indiana-based Cook Medical field safety corrective action informs users that some of its introducer sheaths may be manufactured incorrectly and that the radiopaque marker band may be located just below the Check-Flo proximal fitting instead of the distal tip.

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

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Cook Medical selling powerful Quanta surgical laser in U.S.

Cook Medical announced that the Litho 150 laser from Quanta is now available in the U.S. through its distribution channels.

Bloomington, Ind.-based Cook Medical said in a news release that the Litho 150 is the most recent product in Quanta’s line of laser systems and it complements Cook’s line of urologic stone management disposables. The system has indications for use in a variety of endoscopic and urological surgeries, including benign prostatic hyperplasia procedures and urological stone management.

Litho 150 also consists of an advanced cooling system that makes the machine run quietly, along with a Virtual Basket pulse modulation feature that allows for fine lithotripsy and minimal stone movement without the need for expensive additional fibers, Cook Medical said.

Additionally, Litho 150 includes the Vapor Tunnel low-energy pulse feature designed to create a vapor bubble between the laser tip and stone to allow for a more powerful pulse …

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FDA committee to examine safety of endovascular stent grafts

AFX Endovascular AAA system [Image courtesy of Endologix]FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies.

Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood leakage called Type III endoleaks. Endologix has found itself having to vigorously defend itself against studies claiming a problem.

The FDA is presently advising that anyone with any Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) visits a doctor at least once a year to get checked for leaks.

Another Endologix product — the Ovation iX abdominal stent graft system — was the subject of a Class I recall last year including five deaths, though Endologix clarified that two of the five deaths took place follo…

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Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft

Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft.

The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the clinical trial and premarket review phases. Cook plans to seek an investigational device exemption approval in the coming months, with a pivotal clinical study starting later this year.

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

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The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

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Medtech manufacturers must add warning label to drug-eluting PAD devices

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks.

A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.

Labeling changes will apply to instructions for use of these devices throughout Europe and will  include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No device…

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