Med tech chalks up solid year of new device approvals in 2014

Medical device approvals continued at a steady clip in 2014 despite mounting pressure from lawmakers to roll out a more stringent review process. The FDA granted approvals for 33 innovative devices in 2014, up 43% over the number it OK'ed the year before, according to EP Vantage. FierceMedicalDevices covered device approvals from the first half of the year in an earlier report.

Part of the explanation could be accelerated approvals, as the agency's review times for PMAs during the first half of 2014 rang in at 18.4 months--down from 35.9 months in 2013. But the agency also awarded innovation this past year, signing off on products that filled an unmet need or devices that could have an immediate benefit for patients.

Take DexCom's continuous glucose monitor: In February, the FDA gave the San Diego, CA-based company its blessing for a pediatric version of the device, allowing the product to be used in toddlers and heeding the call for more child-friendly devices. The approval paved the road for another win for the company, as in October, DexCom ($DXCM) got an FDA OK for an updated version of its G4 Platinum continuous glucose monitoring system that wirelessly transmits a patient's glucose levels and reports information through a smartphone.

Then, there was Exact Sciences' ($EXAS) win for its stool-based colorectal cancer test, a noninvasive tool that provides an alternative to traditional screening methods. The agency signed off on the product through a joint pilot program with the Centers for Medicare and Medicaid Services that reduces waiting times between approval and Medicare coverage. Exact's Cologuard test was the first product to take part in the initiative, and the company snagged full Medicare reimbursement a few months after FDA approval.

There were also a fair number of med tech regulatory showdowns in 2014, most notably between Medtronic ($MDT) and archival Edwards Lifesciences ($EW) over competing transcatheter heart valves, and C.R. Bard ($BCR) and Medtronic regarding drug-coated balloon catheters. In January 2014, Medtronic won early FDA approval for its CoreValve system, dealing a blow to Edwards in the companies' ongoing patent litigation over related products. But in June, Edwards struck back with approval for its Sapien XT heart valve, adding fuel to the fire and eyeing sales between $1.0 billion and $1.1 billion in 2015.

In November, Medtronic scored a point against C.R. Bard when the FDA greenlighted its IN.PACT Admiral drug-coated balloon catheter for patients with peripheral artery disease. C.R. Bard had already notched a regulatory win for its product in October, getting an FDA signoff for its Lutonix drug-coated balloon catheter. Both companies are chasing a drug-eluting balloon market that is projected to reach $600 million by fiscal year 2018, according to analyst estimates.

While the following list is not comprehensive, it covers the majority of devices that won the FDA's premarket approval in the second half of 2014, beginning at the end of May. As always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)

May (Check out the report from the first half of 2014 here.)

13. Therascreen KRAS RGQ PCR Kit - Qiagen

Automated Molecular Assay

Approved: May 23

Approval Letter

As med tech companies vie for a place in an increasingly competitive companion diagnostics playing field, Qiagen ($QGEN) scored a major win with approval for its metastatic colorectal cancer test. The Dutch diagnostic giant's Therascreen helps determine which patients would benefit from Amgen's ($AMGN) colorectal cancer drug Vectibix and screens for KRAS mutations which lead to abnormal functioning of genes in colorectal cancer cells. Read more

14. CardioMEMS HF System - CardioMEMS

Pulmonary Artery Pressure

Approved: May 28

Approval Letter

CardioMEMS has faced its fair share of setbacks for its Champion heart failure device, with an FDA panel rejecting the system in 2011 and then casting a mixed vote about its effectiveness in October 2013. But CardioMEMS finally scored a win this past May, as the FDA approved the company's battery-free pulmonary artery implants for patients with heart failure. St. Jude Medical ($STJ) exercised its exclusive right to purchase the company after hearing the news, shelling out $375 million for its remaining stake in CardioMEMS. Read more


15. Artus CMV RGQ MDx Kit - Qiagen

Cytomegalovirus (CMV) DNA Test

Approved: June 2

Approval Letter

Diagnostic heavyweight Qiagen ($QGEN) got a regulatory blessing in June when the FDA signed off on its artus CMV RGQ MDx kit. The product measures the DNA levels of cytomegalovirus (CMV), a common virus that can be fatal to weakened immune systems, in organ transplant patients, and boasts a turnaround time of approximately three hours. Artus runs on the company's Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012. Read more

16. Sapien XT Transcatheter Heart Valve - Edwards Lifesciences

Heart Valve

Approved: June 16

Approval Letter

Edwards Lifesciences ($EW) scored a point against archrival Medtronic ($MDT) in June 2014 when the FDA greenlighted its next-generation transcatheter aortic valve replacement (TAVR) device for high-risk and inoperable patients suffering from severe symptomatic aortic stenosis. The company's Sapien XT has since charted some impressive numbers, pushing Edwards' TAVR sales growth rate to 25% for 2014 and setting the stage for sales of $1.0 billion to $1.1 billion in the coming year. Read more

17. Fluency Plus Endovascular Stent Graft - Bard Peripheral Vascular

Endovascular Stent Graft

Approved: June 17

Approval Letter

C.R. Bard ($BCR) kicked off 2014 with approval for its drug-coated balloon, but the company notched another win under its belt in June when the FDA signed off on its Fluency Plus endovascular stent graft. The device restores blood flow in patients receiving dialysis by reopening a blocked stent and holding the blood vessel wall open. Read more from the FDA

18. Sorin Freedom Solo Stentless Heart Valve and Solo Smart Stentless Heart Valve - Sorin Group Canada

Stentless Heart Valve

Approved: June 24

Approval Letter

Italy's Sorin rolled out a new game plan in 2013, forecasting 4% to 6% annual sales growth for its cardiac surgery business. The devicemaker has not wasted any time since unveiling its heightened forecasts, launching new products and nabbing key regulatory approvals to boost its numbers northward. In 2014, Sorin won FDA approval for its Freedom Solo stentless heart valve, a device made from natural tissue from the heart of a cow that replaces a diseased, damaged or malfunctioning heart valve. The product does not contain any metals or polymers and ensures adequate blood flow to the heart by keeping the aortic valve open and preventing leakage. Read more from the FDA

19. Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) - Boston Scientific


Approved: June 27

Approval Letter

Boston Scientific ($BSX) charged full speed ahead with development of its Rebel Platinum Chromium coronary stent system in 2014, winning a CE mark for the product in March and scoring an FDA approval a few months later to treat patients in the U.S. with coronary artery disease. The device includes much of the same technology as the company's Promus Premier drug-eluting stent and comes in 48 different sizes, including diameters ranging from 2.25 mm to 4.50 mm and lengths ranging from 8 mm to 32 mm. Read more from the FDA


20. Prestige LP Cervical Disc - Medtronic Sofamor Danek USA

Cervical Disc

Approved: July 24

Approval Letter

Medtronic's ($MDT) long-struggling spinal division got a shot of good news in July when the FDA signed off on its Prestige Cervical Disc. Regulators based their decision on a study which compared the device with traditional spinal fusion procedures. The data showed that Prestige charted a 79.3% overall success rate, as opposed to a 66.8% overall success rate in the control group at 24 months. But the FDA's approval comes with a few strings attached, as the agency asked Medtronic to submit a 7-year extended follow-up study of the device. Read more from the FDA

21. Low-Profile Visualized Intraluminal Support Device - MicroVention


Approved: July 25

Approval Letter

California's MicroVention scored a regulatory win in July with FDA approval for its Low-Profile Visualized Intraluminal Support Device. The product, which is used to treat unruptured, wide-neck brain aneurysms, comprises soft platinum coils that prevent blood from flowing toward the aneurysm and keep clots from slipping back into the main blood vessel. Read more from the FDA


22. Cologuard - Exact Sciences

Stool Test

Approved: Aug. 11

Approval Letter

Exact Sciences ($EXAS) did not waste any time bringing its stool-based colorectal cancer test to market in 2014. In August, the Madison, WI-based company won FDA approval for Cologuard through a joint pilot program from the FDA and the Centers for Medicare and Medicaid Services that allows the agencies to simultaneously review medical devices, reducing waiting times between approval and Medicare coverage. A couple of months later, Exact nabbed Medicare reimbursement for its test. The company said it plans to work with private insurers during the coming year to gain additional coverage for Cologuard. Read more

23. XPS System with Steen Solution Perfusate - XVIVO Perfusion

Lung Transplant

Approved: Aug. 12

Approval Letter

Xvivo Perfusion won regulators' blessings in August for its XPS system, a device that preserves lungs that do not initially meet implantation standards and allows transplant teams to further examine the organs to evaluate their function. The FDA gave the device its Humanitarian Use Device designation, which is reserved for products with no market precedent that address an unmet need. Eventually, the device could help reduce waiting times for potential lung transplant recipients and provide a viable treatment option for people with end-stage lung disease. Read more

24. Pleximmune - Plexision

Blood Test

Approved: Aug. 26

Approval Letter

Pittsburgh, PA-based Plexision won an FDA OK in August for Pleximmune, a new blood test that helps predict whether transplanted livers or intestines will be rejected after being implanted in children. The company got a regulatory nod under the agency's Humanitarian Device Exemption program, a category reserved for rare disease populations and devices that fill an unmet need. Plexision touts promising results from the test, which show an overall accuracy approaching or exceeding 80% two months after testing. The results were established after collecting research blood samples from more than 200 children who received liver or intestine transplants at the Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center. Read more

25. SenoClaire - General Electric Healthcare


Approved: Aug. 26

Approval Letter

Med tech companies are homing in on next-generation mammography devices, and GE ($GE) charted progress in the field in August when the FDA signed off on its SenoClaire breast tomosynthesis product. The device, developed in collaboration with Massachusetts General Hospital, uses 2-D imaging to screen for early breast cancer, providing enhanced spectral mammography and automated whole breast ultrasound. Read more


26. Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface - W.L. Gore


Approved: Sept. 19

Approval Letter

W.L. Gore ended 2013 on a sour note, paying rival C.R. Bard ($BCR) the first $36 million of $857.4 million it owes the company from a vascular graft patent suit. But Gore generated some upward momentum in 2014 as the FDA approved a bioactive heparin-coated version of its endoprosthesis device for blood clots. The company's Viabahn Endoprosthesis with Heparin Bioactive Surface is used in patients with peripheral artery disease, improving blood flow to the legs and feet. Regulators called for two postapproval studies of the device as part of the approval, including an extended follow-up comparing treatment with Gore's heparin-coated endoprosthesis to a traditional balloon angioplasty. Read more from the FDA


27. Xience Family of Everolimus Eluting Coronary Stent Systems - Abbott Vascular


Approved: Oct. 3

Approval Letter

Abbott Laboratories ($ABT) did not waste any time with drug-eluting coronary stent devices, rolling out promising study data and chalking up key regulatory approvals for new products. In October, the company won FDA regulators' blessings for additional indications of its Xience family of everolimus-eluting coronary stent systems. The devices are used to treat patients with coronary artery disease by improving blood and oxygen flow to the heart. Meanwhile, Abbott is hard at work on a comparable product, its Absorb Bioresorbable Vascular Scaffold. In September the company unveiled new study data showing that while Absorb did not perform as well as Xience overall, patients with the Absorb stent had less chest pain than those using Xience. Read more from the FDA

28. Lutonix 035 Drug Coated Balloon PTA Catheter - Lutonix


Approved: Oct. 9

Approval Letter

C.R. Bard ($BCR) has long pushed for FDA approval of its Lutonix drug-eluting balloon catheter, citing promising study data that shows the device's effectiveness in preventing restenosis in patients with peripheral artery disease. In October, the company charted a major win after the FDA granted Lutonix its first PMA approval for a drug-coated balloon, allowing the product to be used in arteries in the thighs and knees. The agency based its decision on data which found that 71.8% of Lutonix patients did not require additional treatment at 6 months, compared to 48.6% of patients in the control group. Bard is conducting clinical trials in the U.S. to expand the device's indications for patients with below-the-knee peripheral artery disease, in-stent restenosis and hemodialysis patients who need a synthetic access point. Read more

29. EverFlex Self-Expanding Peripheral Stent System - ev3 (Covidien)


Approved: Oct. 10

Approval Letter

In 2010, Covidien ($COV) paid $2.6 billion for ev3, bolstering its vascular product offerings and focusing on research areas such as angioplasty balloons, plaque removal systems and catheters. Last October, the company reaped some of the fruits of its labor when the FDA approved its EverFlex self-expanding peripheral stent system for patients with atherosclerosis, or the collection of plaque along the lining of the arteries. The device holds open the iliac artery to improve blood flow to the pelvis and legs. Read more from the FDA

30. Dexcom G4 Platinum Continuous Glucose Monitoring System - Dexcom

Glucose Monitoring

Approved: Oct. 21

Approval Letter

Dexcom ($DXCM) chalked up another regulatory win in October, scoring expanded approval for its next-generation mobile communications device for diabetes monitoring. The San Diego, CA-based company's Dexcom Share accessory runs on its G4 Platinum continuous glucose monitoring device that wirelessly transmits patients' glucose levels and reports trending information through a smartphone. The updated FDA approval covers a new version of the G4 system that calculates glucose values from a sensor signal. Read more

31. TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment - St. Jude Medical


Approved: Oct. 24;

Approval Letter

St. Jude Medical ($STJ) set out to expand its electrophysiology offerings in 2014, forging ahead with R&D and making key acquisitions to diversify its portfolio. In October, the company notched another win under its belt as the FDA approved its next-generation TactiCatch Quartz irrigated ablation catheter. The agency based its approval on promising study data which found that 85.5% of patients were free from paroxysmal atrial fibrillation one year after being treated with the device, as opposed to 67.7% of patients who were treated with different ablation catheters. Read more


32. Ideal Implant Saline-filled Breast Implant - Ideal Implant

Breast Implants

Approved: Nov. 14

Approval Letter

Dallas, TX-based Ideal Implant got an FDA green light in November for its Ideal saline-filled breast implant for women at least 18 years old who are undergoing primary breast augmentation to increase breast size, or revision surgery to correct or improve the result of a previous breast augmentation surgery. Regulators attached a few strings to the approval, including a focus group study to determine whether Ideal brochures effectively communicate the risks and benefits of breast implant surgery. Read more from the FDA

33. Animas Vibe System - Animas

Glucose Monitoring

Approved: Nov. 25

Approval Letter

Med tech companies are homing in on next-generation insulin pumps with continuous glucose monitoring (CGM) technology, and Johnson & Johnson's ($JNJ) Animas grabbed a bigger piece of a growing market in November with FDA approval for its Animas Vibe device. The product integrates Dexcom's ($DXCM) Platinum sensing CGM technology and includes a wearable sensor patch, a transmitter and an insulin pump. The pump displays glucose values from the CGM every 5 minutes and also presents glucose trending information, alerts and alarms. Read more


34. Barostim neo Legacy System - CVRx

Implantable Pulse Generator (IPG)

Approved: Dec. 12

Approval Letter not yet available

CVRx is looking to distinguish itself from the cardiovascular pack with its Barostim neo Legacy system, a device that electronically triggers the body's own natural blood flow regulation system to treat chronic heart failure and resistant hypertension. The FDA took heed of the company's product and granted CVRx its Humanitarian Device Exemption (HDE) for Barostim in December. The HDE pathway is reserved for medical devices that treat rare conditions and allows product without market precedent to enter the market. Read more from the FDA

35. BRACAnalysis CDx - Myriad Genetics

Ovarian Cancer

Approved: Dec. 19

Approval Letter

Myriad Genetics ($MYGN) chalked up a regulatory win in December as the FDA approved its companion diagnostic test for AstraZeneca's ($AZN) ovarian cancer drug Lynparza. The company's BRACAnalysis CDx looks at mutations in BRCA1 and BRCA2 genes in blood samples to determine which patients are the best fit for the drug. Regulators reviewed the test under its premarket approval pathway, an accelerated program for high-risk medical devices that have no market precedent and treat or diagnose serious diseases or conditions. Read more

36. Bellafill PMMA Collagen Dermal Filler - Suneva Medical

Dermal filler

Approved: Dec. 23

Approval Letter

In December, San Diego, CA-based Suneva Medical scored FDA approval for Bellafill, an injectable facial implant made from cow tissue and nonabsorbable chemical beads that correct the appearance of acne scars on the cheeks of patients ages 21 and older. The product can also be used to smooth moderate to severe smile lines. Regulators tacked on a condition for its approval, requiring Suneva to submit reports once a year to ensure the device's safety and effectiveness. Read more from the FDA

37. IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter - Medtronic

Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Approved: Dec. 30

Approval Letter

Medtronic ($MDT) expanded its reach in the drug-coated balloon market in December with FDA approval for its IN.PACT Admiral device. The product treats peripheral artery disease in the upper leg, setting the stage for a showdown with C.R. Bard ($BCR), which makes a similar device. FDA approval for IN.PACT also helps Medtronic snag a bigger piece of a market estimated to be worth as much as $600 million by 2018. The company touted positive study data in November for its drug-coated balloon which found that 82.2% of patients experienced restored blood flow through the diseased artery when treated with IN.PACT, as opposed to 52.4% in the traditional angioplasty group. Read more

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