Devicemakers celebrate early regulatory wins despite 2013 setbacks

A slump in FDA premarket approvals in 2013 set a somber tone for the coming year. As EP Vantage reported in its MedTech 2013 in Review, the agency's PMA approval rates were down 44% in 2013 from 2012, with only 23 approvals compared to 41 the previous year. Medical device makers are still struggling to bring their products to market, but a few companies celebrated big regulatory wins in 2014.

Minnesota-based Medtronic ($MDT) scored multiple FDA blessings for a new crop of defibrillators and pacemakers, and took home early approval for its CoreValve transcathether heart valve in the midst of its patent war with Edwards Lifesciences ($EW). After two rejections, Anika Therapeutics ($ANIK) finally got the regulatory go-ahead for its Monovisc osteoarthritis pain injection.

The agency has also awarded innovation this year, giving DexCom ($DXCM) an OK for pediatric use of its continuous glucose monitoring system and Cochlear ($COH) an approval for its next-generation cochlear implant. And in a headlining move, the FDA approved Roche's ($RHHBY) Cobas HPV test for the primary screening of cervical cancer, helping the diagnostics giant grab a larger share of a growing market.

Which company makes it through the door next is anyone's bet, but here are a few device outfits that have managed to score regulatory approvals this year. And for comparison's sake, take a look at the companies who came out on top last year.

As always, feel free to contact us with any comments or questions. --Emily Wasserman (email | Twitter)

1. ReSure Sealant - Ocular Therapeutix

Surgical sealant

Approved: Jan. 8

Approval Letter

Ocular Therapeutix won an FDA OK for its ReSure Sealant gel in January, but not without a few strings attached. Regulators limited the product's use to individuals with clear corneas--an earlier stage of cataracts--and requested a postapproval study on at least 4,857 patients to gather more information on potential problems. ReSure is designed to seal leaks in incisions made during cataract surgery, and is the first gel sealant product to win U.S. regulatory approval for use in the eyes. Read more

2. CoreValve System - Medtronic

Artificial aortic valve

Approved: Jan. 17

Approval Letter

Medtronic ($MDT) picked up ammo in its ongoing patent battle with Edwards ($EW) when the company won early FDA approval in January for its CoreValve transcathether aortic valve replacement (TAVR) device. Although the case recently ended in a settlement, the regulatory blessing boded well for the Minnesota device giant. Regulators approved CoreValve in multiple sizes to treat patients with severe aortic stenosis who are too frail for open heart surgery, forgoing an advisory panel review and citing the device's positive performance in clinical trials. Read more

3. Valiant Thoracic Stent Graft with Captiva Delivery System - Medtronic

Stent graft

Approved: Jan. 22

Approval Letter

Medtronic ($MDT) won a broadened FDA indication for its Valiant Captiva thoracic stent graft system in January, nipping at competitor W.L. Gore's heels. With the regulatory OK, the company followed Flagstaff, AZ-based Gore in stent grafts--a larger, fabric-covered device used to repair blood vessels. Valiant Captiva was approved in November 2012 to treat aortic injuries from major accidents, but the product is now approved to treat aneurysms and penetrating ulcers. Read more

4. Dexcom G4 Platinum (Pediatric) Continuous Glucose Monitoring System - Dexcom

Glucose monitoring

Approved: Feb. 3

Approval Letter

Dexcom ($DXCM) picked up FDA approval for its Dexcom G4 Platinum continuous glucose monitoring system in February, becoming one of the few companies to offer medical devices geared toward children. The San Diego-based company's continuous glucose monitoring system can now be used in children between the ages of 2 to 17 and boasts a slim, wireless interface that reports trending information in real time for up to 7 days. Read more

5. Monovisc - Anika Therapeutics


Approved: Feb. 25

Approval Letter

The third time was a charm for Anika ($ANIK), as the company secured FDA approval for its osteoarthritis (OA) pain injection in February after two biting rejections. Monovisc consists of a single-shot formulation of bacteria-derived hyaluronic acid that eases knee pain in OA sufferers who do not respond to traditional analgesics. The regulatory OK boosted the biotech's shares by almost 40%, setting the stage for growth in the coming year. Read more

6. Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg - Roche

Hepatitis B test

Approved: March 14

Approval Letter

Long known for its diagnostic assays, Roche ($RHHBY) won FDA approval in March for its Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg tests for hepatitis B. The diagnostic is used in combination with other clinical information and blood test to help uncover the disease in adult patients. More from the FDA

7. Nucleus Hybrid L24 Cochlear Implant System - Cochlear

Cochlear implant system

Approved: March 20

Approval Letter

Cochlear ($COH) needed a pick-me-up in 2014, and the company received it with FDA approval of its next-generation cochlear implant system. The Australian company downgraded its profit forecasts for the second half of its FY 2013--a change it blamed on customer holdout for its Nucleus 6 device--and saw its profits fall by 68% in 2012 after a costly recall of another cochlear implant product. Cochlear's Nucleus Hybrid L24 Cochlear implant system was OK'd in March for individuals 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds, and boasts innovative features like manually adjustable sound settings and wireless data streaming. Read more

8. Supera Peripheral Stent System - Abbott

Peripheral stent

Approved: March 28

Approval Letter

Abbott ($ABT) won FDA approval for its Supera Peripheral Stent System in March, clearing the device of its last regulatory hurdle. The company inherited Supera from Texas-based Idev Technologies, which Abbott snagged last July for $310 million. The self-expanding nitinol stent already had a CE mark, and was under review by the FDA at the time of the acquisition. Read more

9. Medtronic CRT-P and CRT-D Devices - Medtronic


Approved: April 10

Approval Letter

It has been a rough year for Medtronic ($MDT), as the med tech giant faced courtroom battles over its transcatheter heart valve and disappointing trial results for its renal denervation therapy. Still, the company enjoyed a bright point as the FDA approved a new crop of its signature pacemakers and defibrillators for use in patients with less severe heart failure. The devices were already approved for use in individuals with right ventricle heart failure, but the extended indication covers patients with atrioventricular block and left ventricular block dysfunction. Read more

10. Cobas HPV Test - Roche

HPV test

Approved: April 24

Approval Letter

Roche ($RHHBY) traveled down a long road to gain FDA approval for its Cobas HPV test. In 2011, the company got a regulatory OK to use the test to screen patients 21 and older who presented abnormal cytology results, and to identify high-risk HPV genotypes in women 30 and older. April's PMA approval makes Cobas the first HPV test cleared for primary screening of cervical cancer, and could help the Swiss company increase its 20% share in the global diagnostics market. Read more

11. Inspire Upper Airway Stimulation - Inspire Medical Systems

Obstructive sleep apnea

Approved: April 30

Approval Letter not yet available

Inspire Medical Systems has not wasted any time since securing FDA approval for its Inspire sleep apnea device in April. Weeks after getting a regulatory green light, the Minneapolis-based company brought in $40 million in Series E money to use for the U.S. launch of its Inspire Upper Airway Stimulation System. Inspire's nerve stimulation implant treats moderate to severe obstructive sleep apnea by stimulating a nerve in a person's jaw, and is implanted in the chest similarly to a pacemaker. The company touts the device as a less bulky alternative to continuous positive airway pressure therapy machines. Read more

12. GEL-SYN - Institut Biochimique


Approved: May 9

Approval Letter not yet available

Switzerland's Institut Biochimique secured an FDA blessing for its GEL-SYN material earlier this month, joining the ranks of other companies who are shifting their focus toward a profitable orthopedic market. GEL-SYN is injected into osteoarthritic knees to relieve pain, lubricate the joint and absorb shock. Read more from the FDA

- get more from the FDA
- here's the EP Vantage report

Special Report: 2013's top FDA approvals in med tech

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